Module title: Clinical trial phases
Lesson titles
- Why trials have phases
- Early development and phases I and II
- Phases III and IV
- Compare the evidence
- Put the phases into practice
- Check and keep the essentials
Module objectives
- Using the phase guide when needed, identify phases I to IV correctly from four short trial descriptions.
- Using a comparison guide, match all four phases to their main question and recognise how safety evidence develops.
- Choose accurate wording for three fictional internal updates about trial evidence.
Lesson 1: Why trials have phases
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S000 | Visual direction: Use the course title and introduction beside a supporting clinical image, with a Start Course control and lesson list beneath. On-screen text: Clinical Trial Phases Follow a fictional medicine through development. Discover what each phase investigates, compare the evidence and practise writing accurate updates about trial progress. A 20 to 25 minute introduction for non-clinical pharmaceutical staff. START COURSE Why trials have phases Early development and phases I and II Phases III and IV Compare the evidence Put the phases into practice Check and keep the essentials | Narration: Not applicable On-screen instruction: Select START COURSE or choose a lesson. | Select START COURSE to begin the first lesson, or select a lesson title to open that lesson. | Keep lesson navigation available for returning to the guide and reference content. |
| M1.S001 | Visual direction: Use a wide clinical image as a visual introduction, above the section narration and teaching. On-screen text: No on-screen text. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Treat this supporting photograph as decorative; essential learning content must remain in the adjacent text. |
| M1.S002 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Understanding Clinical Trial Phases | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S003 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Understanding Clinical Trial Phases” - narrates the introduction and objectives below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Understanding Clinical Trial Phases. You do not need to run a trial to encounter its results. You might prepare an onboarding pack, coordinate a project or write an internal update. Recognising the phase helps you ask the right question and avoid overstating what the evidence shows. In this course, you will follow C T one hundred and one, a fictional medicine being investigated for a long-term inflammatory condition. The company, medicine and study details are invented for learning. By the end, using the phase guide when needed, you will be able to identify phases one to four correctly from four short trial descriptions. Using a comparison guide, match all four phases to their main question and recognise how safety evidence develops. Choose accurate wording for three fictional internal updates about trial evidence. You will practise before the final checks and can retry after feedback. Narration is optional throughout. Select Play to listen, Pause to stop, or continue reading without playing audio. Select Continue when you are ready for the next section. On-screen instruction: Listen to “Understanding Clinical Trial Phases” - narrates the introduction and objectives below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S004 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: You do not need to run a trial to encounter its results. You might prepare an onboarding pack, coordinate a project or write an internal update. Recognising the phase helps you ask the right question and avoid overstating what the evidence shows. In this course, you will follow CT-101, a fictional medicine being investigated for a long-term inflammatory condition. The company, medicine and study details are invented for learning. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S005 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: By the end, using the phase guide when needed, you will be able to do the following. You will practise before the final checks and can retry after feedback. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S006 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Using the phase guide when needed, identify phases I to IV correctly from four short trial descriptions. 2. Using a comparison guide, match all four phases to their main question and recognise how safety evidence develops. 3. Choose accurate wording for three fictional internal updates about trial evidence. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S007 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S008 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Clinical trials and safeguards | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S009 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Clinical trials and safeguards” - narrates the explanation and introduces the safeguards below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: A clinical trial is research involving people that evaluates a health intervention. Here, we focus on trials of medicines. A trial follows a protocol: a planned description of its question, participants, treatment, assessments and analysis. The protocol helps the team collect evidence that can answer the research question. Key safeguards in every clinical trial. Clinical trials use safeguards intended to protect participants. Open each panel to read about the safeguards. A phase label never means that risk has disappeared. A later phase can provide stronger evidence for a particular question. It does not prove that a medicine has no risks, will benefit everyone or will receive authorisation. On-screen instruction: Listen to “Clinical trials and safeguards” - narrates the explanation and introduces the safeguards below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S010 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: A clinical trial is research involving people that evaluates a health intervention. Here, we focus on trials of medicines. A trial follows a protocol: a planned description of its question, participants, treatment, assessments and analysis. The protocol helps the team collect evidence that can answer the research question. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S011 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Key Safeguards in Every Clinical Trial Clinical trials use safeguards intended to protect participants. Explore the panels below. A phase label never means that risk has disappeared. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S012 | Visual direction: Stack clearly labelled expandable panels beneath the section introduction. On-screen text: Labels: Informed consent for all participants; Right to withdraw at any time; Ongoing oversight and safety checks | Narration: Not applicable On-screen instruction: Open the panels to read the safeguards. | Expand and collapse each panel to review its explanation. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S012.01 | Visual direction: Show the Informed consent for all participants explanation within the same interaction. On-screen text: Informed consent for all participants Participants receive relevant information about the study, its possible benefits, risks and practical commitments, and have opportunities to ask questions. Participation is voluntary. Consent is an ongoing process. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Informed consent for all participants to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S012.02 | Visual direction: Show the Right to withdraw at any time explanation within the same interaction. On-screen text: Right to withdraw at any time People can choose to leave a trial. Their decision must not compromise their usual care. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Right to withdraw at any time to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S012.03 | Visual direction: Show the Ongoing oversight and safety checks explanation within the same interaction. On-screen text: Ongoing oversight and safety checks The research team monitors participants and reviews emerging information. A phase label never means that risk has disappeared. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Ongoing oversight and safety checks to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S013 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: A later phase can provide stronger evidence for a particular question. It does not prove that a medicine has no risks, will benefit everyone or will receive authorisation. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S014 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: The Medicine Development Roadmap | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S015 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “The Medicine Development Roadmap” - introduces the roadmap activity below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: The medicine development roadmap. This is a simplified journey. Programmes may stop, revise, overlap or combine stages. Select Start and use the step controls to explore the roadmap. Read each step to discover how the research question changes. Regulatory review is a separate decision. Safety evidence develops throughout and continues after authorisation. Trial milestones do not prove the absence of all risks or guarantee authorisation. On-screen instruction: Listen to “The Medicine Development Roadmap” - introduces the roadmap activity below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S016 | Visual direction: Use the evidence infographic at a readable width, with the related teaching text close by. On-screen text: Image alternative text: Simplified medicine-development roadmap: preclinical work, Phases I to III, separate regulatory review, then Phase IV. Safety evidence develops throughout. Full step descriptions follow. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Provide equivalent alternative text: Simplified medicine-development roadmap: preclinical work, Phases I to III, separate regulatory review, then Phase IV. Safety evidence develops throughout. Full step descriptions follow. |
| M1.S017 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: This is a simplified medicine-development journey. Programmes may stop, revise, overlap or combine stages. Regulatory review is a separate decision. Safety evidence develops throughout and continues after authorisation. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S018 | Visual direction: Show a step-by-step development roadmap with an introduction, six steps and a summary; keep navigation below the current panel. On-screen text: Labels: The development roadmap; Before studies in people; Phase I trials; Phase II trials; Phase III trials; Regulatory review; Phase IV; Summary Controls: START; next step; previous step; step navigation. | Narration: Not applicable On-screen instruction: Explore the roadmap steps and notice the separate regulatory review decision. | Select START, then move through the six steps and summary. Use previous, next or step controls to revisit content. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S018.01 | Visual direction: Show the The development roadmap explanation within the same interaction. On-screen text: The development roadmap This is a simplified medicine-development journey. Programmes may stop, revise, overlap or combine stages. Explore the steps and notice the separate review decision. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.02 | Visual direction: Show the Before studies in people explanation within the same interaction. On-screen text: Before studies in people Laboratory and preclinical work help researchers decide whether and how to begin human studies. These are not Phase I trials. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.03 | Visual direction: Show the Phase I trials explanation within the same interaction. On-screen text: Phase I trials Explore tolerability, dose and what happens to the medicine in the body. Participants may be healthy volunteers or people with the condition, depending on the programme. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.04 | Visual direction: Show the Phase II trials explanation within the same interaction. On-screen text: Phase II trials Investigate early evidence of benefit in people with the condition and refine the dose and study approach. Safety is still evaluated. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.05 | Visual direction: Show the Phase III trials explanation within the same interaction. On-screen text: Phase III trials Evaluate benefit and risk in larger studies, usually with an appropriate comparator. Study designs and participant numbers vary. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.06 | Visual direction: Show the Regulatory review explanation within the same interaction. On-screen text: Regulatory review Authorities assess the submitted evidence and decide whether the medicine may be marketed for a specified use. Completing Phase III does not itself grant authorisation. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.07 | Visual direction: Show the Phase IV explanation within the same interaction. On-screen text: Phase IV After authorisation, further studies can examine use, benefits and risks. Routine safety reporting and other monitoring also continue beyond formal trials. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S018.08 | Visual direction: Show the Summary explanation within the same interaction. On-screen text: Summary Safety evidence develops throughout. Trial milestones do not prove the absence of all risks or guarantee authorisation. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the step or use the forward and back controls to read this panel. Return to any step for reference. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S019 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Check your starting point | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S020 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Check your starting point” - introduces the question below and the next lesson. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Check your starting point. Which question is most useful when identifying a trial phase? Read the choices on screen, select an answer and Submit. Use the feedback to review your reasoning. You can retry. In the next lesson, you will explore how early-phase studies begin to build the evidence for a new medicine, and what questions each phase is designed to answer. On-screen instruction: Listen to “Check your starting point” - introduces the question below and the next lesson. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S021 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: Which question is most useful when identifying a trial phase? Choices: What is the study mainly designed to find out? Does the study have a large budget? Is the medicine already well known to the company? Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S021.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Correct. Purpose is the strongest starting point. The phase guide helps you interpret the purpose alongside the study context. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “What is the study mainly designed to find out?” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S021.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Budget is not a reliable phase identifier. Look for the question the protocol is designed to answer. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Does the study have a large budget?” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S021.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Familiarity within the company does not define a trial phase. Look for the study’s main research purpose. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Is the medicine already well known to the company?” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S022 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In the next lesson, you’ll explore how early-phase studies begin to build the evidence for a new medicine, and what questions each phase is designed to answer. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
Lesson 2: Early development and phases I and II
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S023 | Visual direction: Use a wide clinical image as a visual introduction, above the section narration and teaching. On-screen text: No on-screen text. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Treat this supporting photograph as decorative; essential learning content must remain in the adjacent text. |
| M1.S024 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Early Clinical Trials: From Lab to People | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S025 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Early Clinical Trials: From Lab to People” - narrates the section below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Early clinical trials: from lab to people. C T one hundred and one has completed the fictional programme’s preclinical work. The team is considering studies in people. Morgan, a new project coordinator, wants to know what the early studies can establish. The following examples are simplified and invented. They are not a protocol or instructions for giving a medicine. Start with the research question, then look at the participants and evidence. In this lesson, you will focus on the earliest clinical trial phases and how to interpret their findings. Identify the main objectives and participant groups of phase one and phase two trials. Recognise the types of evidence each phase provides. Practise describing early phase findings accurately in internal updates. Select Continue when you are ready. Listening is optional; you can read every section instead. On-screen instruction: Listen to “Early Clinical Trials: From Lab to People” - narrates the section below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S026 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: CT-101 has completed the fictional programme’s preclinical work. The team is considering studies in people. Morgan, a new project coordinator, wants to know what the early studies can establish. The following examples are simplified and invented. They are not a protocol or instructions for giving a medicine. Start with the research question, then look at the participants and evidence. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S027 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In this lesson, you’ll focus on the earliest clinical trial phases and how to interpret their findings. By the end, you should be able to: | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S028 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Identify the main objectives and participant groups of Phase I and Phase II trials. 2. Recognise the types of evidence each phase provides. 3. Practise describing early phase findings accurately in internal updates. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S029 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S030 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Phase I: Purpose, Participants, and Evidence | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S031 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Phase I: Purpose, Participants, and Evidence” - narrates the teaching and introduces the practice below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Phase one: purpose, participants and evidence. Select each tab and read about the study’s purpose, participants, evidence and how the results are used. Phase one studies begin building clinical evidence about tolerability, dose and the medicine’s behaviour in the body. Participants are closely monitored. Some programmes involve healthy volunteers; others involve people with the condition. The findings help determine whether and how further investigation should proceed. For the check below, read the study description and Morgan’s proposed update. Choose what needs correcting, then select Submit. Read the feedback and retry if needed. On-screen instruction: Listen to “Phase I: Purpose, Participants, and Evidence” - narrates the teaching and introduces the practice below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S032 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Explore each aspect of Phase I to understand its purpose and design. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S033 | Visual direction: Use a horizontal row of labelled tabs above a shared reading panel. On-screen text: Labels: Main Question; Who Takes Part; What Evidence Is Gathered; How Results Are Used | Narration: Not applicable On-screen instruction: Select each tab to explore the phase. | Select a tab to display its explanation; revisit other tabs as needed. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S033.01 | Visual direction: Show the Main Question explanation within the same interaction. On-screen text: Main Question How is the medicine tolerated, which doses can be investigated and what happens to it in the body? | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Main Question to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S033.02 | Visual direction: Show the Who Takes Part explanation within the same interaction. On-screen text: Who Takes Part Often a small group of healthy volunteers. Some programmes, including many cancer studies, involve people with the condition. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Who Takes Part to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S033.03 | Visual direction: Show the What Evidence Is Gathered explanation within the same interaction. On-screen text: What Evidence Is Gathered Researchers closely observe participants and collect information about tolerability, dose and the medicine’s behaviour in the body. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select What Evidence Is Gathered to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S033.04 | Visual direction: Show the How Results Are Used explanation within the same interaction. On-screen text: How Results Are Used Findings inform later study design. They do not establish broad treatment benefit on their own. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select How Results Are Used to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S034 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: A closely monitored fictional study of CT-101 investigates tolerability and how the medicine behaves in the body. Morgan drafts: “We have proved CT-101 works for patients.” What needs correcting? Choices: The study’s purpose does not establish treatment benefit for patients. The sentence is accurate because the study involved people. The only problem is that the phase number is missing. Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S034.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Correct. A useful early study is not proof of benefit for the intended patient population. Describe the evidence actually gathered. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “The study’s purpose does not establish treatment benefit for patients.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S034.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Human participation alone does not establish effectiveness. This study focuses on tolerability and the medicine’s behaviour in the body. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “The sentence is accurate because the study involved people.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S034.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Adding Phase I would not fix the unsupported claim. The wording must reflect the study’s purpose and findings. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “The only problem is that the phase number is missing.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S035 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Phase I in Action Phase I studies begin building clinical evidence about tolerability, dose and the medicine’s behaviour in the body. Participants are closely monitored. Some programmes involve healthy volunteers; others involve people with the condition. The findings help determine whether and how further investigation should proceed. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S036 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Phase II: Building on Early Evidence | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S037 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Phase II: Building on Early Evidence” - narrates the teaching and introduces the practice below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Phase two: building on early evidence. Explore the tabs to read its key features. In the fictional C T one hundred and one programme, a phase two study reports an encouraging change in a planned symptom measure. The team proposes a larger study. A careful update says: These findings support further investigation. The next study will test the treatment effect more fully. It would be premature to write: C T one hundred and one is ready for routine use. A promising result and a marketing authorisation are different things. Phase two trials gather early evidence about whether a medicine might help people with the condition, while continuing to monitor safety. The findings guide decisions about moving to larger, more definitive studies. For the check, read the study description and select the phase that best fits its main purpose. Select Submit, read the feedback and retry if needed. On-screen instruction: Listen to “Phase II: Building on Early Evidence” - narrates the teaching and introduces the practice below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S038 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Now explore the key features of Phase II and how it builds on early evidence. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S039 | Visual direction: Use a horizontal row of labelled tabs above a shared reading panel. On-screen text: Labels: Main Question; Who Takes Part; What Evidence Is Gathered; How Results Are Used | Narration: Not applicable On-screen instruction: Select each tab to explore the phase. | Select a tab to display its explanation; revisit other tabs as needed. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S039.01 | Visual direction: Show the Main Question explanation within the same interaction. On-screen text: Main Question Does the medicine show evidence of benefit in people with the condition, and what dose and study approach should be investigated further? | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Main Question to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S039.02 | Visual direction: Show the Who Takes Part explanation within the same interaction. On-screen text: Who Takes Part People with the condition being studied. Groups are usually larger than early Phase I groups, but size varies. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Who Takes Part to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S039.03 | Visual direction: Show the What Evidence Is Gathered explanation within the same interaction. On-screen text: What Evidence Is Gathered Measures of treatment effect, continued safety information and information that helps refine later trials. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select What Evidence Is Gathered to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S039.04 | Visual direction: Show the How Results Are Used explanation within the same interaction. On-screen text: How Results Are Used The programme may proceed, change or stop. Encouraging findings do not replace the evidence needed from later confirmatory work. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select How Results Are Used to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S040 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In the fictional CT-101 programme, a Phase II study reports an encouraging change in a planned symptom measure. The team proposes a larger study. A careful update says: “These findings support further investigation. The next study will test the treatment effect more fully.” It would be premature to write: “CT-101 is ready for routine use.” A promising result and a marketing authorisation are different things. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S041 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: A study involves people with the condition and investigates an early treatment effect while refining the dose for later studies. Which main phase best fits? Choices: Phase I Phase II Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S041.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase I usually focuses on early tolerability, dose and behaviour in the body. This description emphasises early benefit in the target patient group and preparation for later studies. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase I” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S041.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Correct. The combination of early treatment-effect evidence and dose refinement fits Phase II. Safety is still evaluated. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S041.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase IV concerns studies after authorisation. No authorisation is described here. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S042 | Visual direction: Use the evidence infographic at a readable width, with the related teaching text close by. On-screen text: No on-screen text. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Treat this supporting photograph as decorative; essential learning content must remain in the adjacent text. |
| M1.S043 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Phase II in Focus Phase II trials gather early evidence about whether a medicine might help people with the condition, while continuing to monitor safety. The findings guide decisions about moving to larger, more definitive studies. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S044 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Key Early-Phase Terms | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S045 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Key Early-Phase Terms” - introduces the flashcard activity below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Key early-phase terms. Flip each card and read its definition. Use these terms when interpreting study descriptions. Then revisit the early-phase checks if you need more practice. Describe the evidence actually gathered, rather than promising success. On-screen instruction: Listen to “Key Early-Phase Terms” - introduces the flashcard activity below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S046 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Flip each card to review important terms you’ll encounter in trial descriptions. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S047 | Visual direction: Arrange four cards in a readable grid, with the term on the front and definition on the back. On-screen text: Labels: Efficacy; Endpoint; Adverse event; Protocol | Narration: Not applicable On-screen instruction: Flip each card to review the term. | Flip cards to review their definitions; flip them back as needed. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S047.01 | Visual direction: Show the Efficacy explanation within the same interaction. On-screen text: Front: Efficacy Back: How well an intervention produces its intended effect under the conditions of a study. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Flip Efficacy to read its definition. Flip again to return to the term. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S047.02 | Visual direction: Show the Endpoint explanation within the same interaction. On-screen text: Front: Endpoint Back: A defined outcome measured to answer a research question, such as a change in symptoms at a specified time. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Flip Endpoint to read its definition. Flip again to return to the term. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S047.03 | Visual direction: Show the Adverse event explanation within the same interaction. On-screen text: Front: Adverse event Back: An unwanted medical occurrence during a study. It is not automatically caused by the study medicine. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Flip Adverse event to read its definition. Flip again to return to the term. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S047.04 | Visual direction: Show the Protocol explanation within the same interaction. On-screen text: Front: Protocol Back: The plan describing how a study will be conducted and evaluated. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Flip Protocol to read its definition. Flip again to return to the term. | Keep this content available as text; do not add narration that reads the expanded content. |
Lesson 3: Phases III and IV
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S048 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Phases III and IV: Building and Testing Evidence at Scale | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S049 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Phases III and IV: Building and Testing Evidence at Scale” - narrates the introduction and objectives below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Phases three and four: building and testing evidence at scale. The fictional C T one hundred and one programme has reached larger studies. Morgan now needs to distinguish stronger clinical evidence, the regulator’s separate decision, and research after authorisation. Phase three asks about benefit and risk in a larger group. Phase four investigates questions after a medicine is authorised. Neither phase removes all uncertainty. In this lesson, focus on the advanced phases of clinical trials and what sets them apart. Identify objectives and participants in phases three and four. Recognise fair comparison in clinical studies. Distinguish trial evidence from regulatory authorisation. Select Continue when you are ready. You can listen or read. On-screen instruction: Listen to “Phases III and IV: Building and Testing Evidence at Scale” - narrates the introduction and objectives below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S050 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: The fictional CT-101 programme has reached larger studies. Morgan now needs to distinguish stronger clinical evidence, the regulator’s separate decision, and research after authorisation. Phase III asks about benefit and risk in a larger group. Phase IV investigates questions after a medicine is authorised. Neither phase removes all uncertainty. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S051 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In this lesson, you’ll focus on the advanced phases of clinical trials and what sets them apart. Review the objectives below to see what you’ll be able to do by the end of this lesson: | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S052 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Identify objectives and participants in Phases III and IV 2. Recognise fair comparison in clinical studies 3. Distinguish trial evidence from regulatory authorisation | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S053 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S054 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Phase III: Purpose, Design, and Impact | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S055 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Phase III: Purpose, Design, and Impact” - narrates the teaching and introduces the comparison activity below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Phase three: purpose, design and impact. Select each tab to read about its purpose, participant group, comparison and evidence. In the simplified fictional study, C T one hundred and one is compared with an appropriate comparator. Explore the labelled graphic and select each marker to read about the features of a fair comparison. Completing phase three does not automatically authorise a medicine. Study results contribute to an evidence package. Regulatory authorities assess the submitted evidence for the proposed use. A programme may not proceed if the evidence or overall benefit-risk assessment is insufficient. The details of authorisation vary by jurisdiction. On-screen instruction: Listen to “Phase III: Purpose, Design, and Impact” - narrates the teaching and introduces the comparison activity below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S056 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Explore each aspect of Phase III to understand its purpose, design, and impact. Expand each tab to learn how this phase builds robust evidence for new medicines. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S057 | Visual direction: Use a horizontal row of labelled tabs above a shared reading panel. On-screen text: Labels: Main Question; Participant Group; Structure of Comparison; Evidence Generated | Narration: Not applicable On-screen instruction: Select each tab to explore the phase. | Select a tab to display its explanation; revisit other tabs as needed. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S057.01 | Visual direction: Show the Main Question explanation within the same interaction. On-screen text: Main Question What does a larger study show about treatment benefit and risk in the intended population? | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Main Question to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S057.02 | Visual direction: Show the Participant Group explanation within the same interaction. On-screen text: Participant Group Usually larger patient groups, sometimes across multiple sites or countries. Numbers vary with the question and design. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Participant Group to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S057.03 | Visual direction: Show the Structure of Comparison explanation within the same interaction. On-screen text: Structure of Comparison Many studies compare the new medicine with standard treatment or another appropriate comparator. Not every Phase III study uses a placebo or proves superiority. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Structure of Comparison to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S057.04 | Visual direction: Show the Evidence Generated explanation within the same interaction. On-screen text: Evidence Generated Findings help inform benefit-risk evaluation and a potential submission for authorisation. Important uncertainty can remain. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Evidence Generated to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S058 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Key Elements of a Fair Comparison in Phase III Trials This simplified fictional study compares CT-101 with an appropriate comparator. 1. Eligible participants: The protocol defines who can join. Its criteria help researchers study the intended question. 2. Allocation by chance: Randomisation assigns participants to groups by chance, helping reduce systematic differences between groups. 3. Comparator: A comparator gives the team a basis for comparison. It may be standard treatment or a placebo where appropriate; a placebo is not always suitable. 4. Common outcome assessment: Outcomes are measured using the planned approach. Masking can reduce bias by keeping specified people unaware of which treatment was assigned, where feasible. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S059 | Visual direction: Show a two-group trial-comparison diagram with four markers aligned to the features they explain. On-screen text: Labels: Eligible participants; Allocation by chance; Appropriate comparator; Common outcome assessment | Narration: Not applicable On-screen instruction: Select the markers to explore the comparison features. | Open a marker to read its explanation; close it to return to the diagram. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. Provide alternative text: Simplified trial comparison: eligible participants are allocated by chance to study treatment or an appropriate comparator, then assessed using common outcomes. The four features are explained in the text above. |
| M1.S059.01 | Visual direction: Show the Eligible participants explanation within the same interaction. On-screen text: Eligible participants The protocol defines who can join. Its criteria help researchers study the intended question. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the marker for Eligible participants to open its explanation, then close it or select another marker. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S059.02 | Visual direction: Show the Allocation by chance explanation within the same interaction. On-screen text: Allocation by chance Randomisation assigns participants to groups by chance, helping reduce systematic differences between groups. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the marker for Allocation by chance to open its explanation, then close it or select another marker. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S059.03 | Visual direction: Show the Appropriate comparator explanation within the same interaction. On-screen text: Appropriate comparator A comparator gives the team a basis for comparison. It may be standard treatment or a placebo where appropriate; a placebo is not always suitable. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the marker for Appropriate comparator to open its explanation, then close it or select another marker. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S059.04 | Visual direction: Show the Common outcome assessment explanation within the same interaction. On-screen text: Common outcome assessment Outcomes are measured using the planned approach. Masking can reduce bias by keeping specified people unaware of which treatment was assigned, where feasible. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select the marker for Common outcome assessment to open its explanation, then close it or select another marker. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S060 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Completing Phase III does not automatically authorise a medicine. Study results contribute to an evidence package. Regulatory authorities assess the submitted evidence for the proposed use. A programme may not proceed if the evidence or overall benefit-risk assessment is insufficient. The details of authorisation vary by jurisdiction. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S061 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Phase IV: Ongoing Evidence After Authorisation | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S062 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Phase IV: Ongoing Evidence After Authorisation” - narrates the teaching and introduces the practice below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Phase four: ongoing evidence after authorisation. Explore the tabs to read about its role and the distinction between formal trials and wider monitoring. Phase four trials investigate additional questions after authorisation. The question determines the participants and design. A trial may address longer-term effects or questions about use; routine safety reporting also continues outside formal trials. New evidence can change the understanding of a medicine’s benefits and risks. For the check below, read the study description and choose the phase that best fits. Select Submit, read the feedback and retry if needed. On-screen instruction: Listen to “Phase IV: Ongoing Evidence After Authorisation” - narrates the teaching and introduces the practice below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S063 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Explore each aspect of Phase IV to understand its ongoing role after authorisation. Expand each tab to see how post-marketing studies contribute to medicine safety and effectiveness. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S064 | Visual direction: Use a horizontal row of labelled tabs above a shared reading panel. On-screen text: Labels: Main Question; Context; Evidence Generated; Formal Trials vs. Safety Monitoring | Narration: Not applicable On-screen instruction: Select each tab to explore the phase. | Select a tab to display its explanation; revisit other tabs as needed. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S064.01 | Visual direction: Show the Main Question explanation within the same interaction. On-screen text: Main Question What more can be learned about the authorised medicine’s use, benefits and risks? | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Main Question to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S064.02 | Visual direction: Show the Context explanation within the same interaction. On-screen text: Context Studies take place after marketing authorisation. Their questions, populations and designs vary. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Context to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S064.03 | Visual direction: Show the Evidence Generated explanation within the same interaction. On-screen text: Evidence Generated Further information can address longer-term effects, less common risks or questions about use. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Evidence Generated to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S064.04 | Visual direction: Show the Formal Trials vs. Safety Monitoring explanation within the same interaction. On-screen text: Formal Trials vs. Safety Monitoring Formal Phase IV trials are part of a wider picture. Routine safety reporting and other post-authorisation evidence collection are not all Phase IV trials. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Formal Trials vs. Safety Monitoring to display its explanation. Select another tab to replace the reading panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S065 | Visual direction: Use the evidence infographic at a readable width, with the related teaching text close by. On-screen text: No on-screen text. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Treat this supporting photograph as decorative; essential learning content must remain in the adjacent text. |
| M1.S066 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Phase IV in the Real World Phase IV trials investigate additional questions after authorisation. The question determines the participants and design. A trial may address longer-term effects or questions about use; routine safety reporting also continues outside formal trials. New evidence can change the understanding of a medicine’s benefits and risks. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S067 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: CT-101 has received authorisation in this fictional example. A new trial investigates an unresolved question about longer-term use. Which phase best fits? Choices: Phase II Phase III Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S067.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase II usually investigates early benefit before authorisation. The key detail here is that the medicine is already authorised. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S067.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase III typically provides larger-scale evidence before a potential authorisation submission. This trial takes place after authorisation. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase III” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S067.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Correct. A formal post-authorisation trial fits Phase IV. Its existence does not mean all post-authorisation safety work is a trial. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
Lesson 4: Compare the evidence
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S068 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Comparing Clinical Trial Phases | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S069 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Comparing Clinical Trial Phases” - narrates the introduction and objectives below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Comparing clinical trial phases. Morgan has four study summaries on the desk. The phase labels are useful, but they are only the start. Read the purpose and context, then use the evidence guide to organise the summaries. This is supported practice: you can revisit the guide and try again. Safety evidence develops throughout the programme. In this lesson, develop your ability to compare and interpret clinical trial phases. Identify key variations in clinical trial phases and design. Use comparison guides to match study purposes to phases. Recognise how safety evidence develops throughout the clinical programme. Select Continue when ready. On-screen instruction: Listen to “Comparing Clinical Trial Phases” - narrates the introduction and objectives below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S070 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Morgan has four study summaries on the desk. The phase labels are useful, but they are only the start. Read the purpose and context, then use the evidence guide to organise the summaries. This is supported practice: you can revisit the guide and try again. Safety evidence develops throughout the programme. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S071 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In this lesson, you'll focus on developing your ability to compare and interpret clinical trial phases. The following objectives will guide your learning and help you apply these skills in your daily work: | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S072 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Identify key variations in clinical trial phases and design. 2. Use comparison guides to match study purposes to phases. 3. Recognise how safety evidence develops throughout the clinical programme. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S073 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S074 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Key Variations in Clinical Trial Design and Labelling | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S075 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Key Variations in Clinical Trial Design and Labelling” - narrates the explanation and comparison guide below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Key variations in clinical trial design and labelling. Clinical trials can vary significantly in their design and labelling, depending on the goals of the study and the intervention being tested. Open each panel and read about the variations. Four questions. One developing evidence picture. Phase labels are a helpful starting point, but real-world trials often follow more complex paths. To interpret results accurately, always look at the main research question and the study’s design, not just the phase name. Safety evidence develops throughout the programme. Identify the purpose and context first. Participant numbers are supporting clues, not fixed boundaries. Use the comparison guide to review each phase’s purpose. Optional phase zero is a very early exploratory study in some programmes. Phase one asks: How is it tolerated, what doses can be explored and what happens in the body? Phase two asks: Is there an early treatment signal in people with the condition, and how should later studies be refined? Phase three asks: What does larger-scale evaluation show about benefit and risk? Phase four asks: What more can be learned after authorisation? On-screen instruction: Listen to “Key Variations in Clinical Trial Design and Labelling” - narrates the explanation and comparison guide below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S076 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Clinical trials can vary significantly in their design and labelling, depending on the goals of the study and the type of intervention being tested. Understanding these variations helps clarify how new treatments are developed and evaluated. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S077 | Visual direction: Stack clearly labelled expandable panels beneath the section introduction. On-screen text: Labels: Combined Phases; Phase 0 Studies; Pausing or Revising a Programme; Different Types of Interventions | Narration: Not applicable On-screen instruction: Open each panel to read the variations. | Expand and collapse each panel to review its explanation. | Use logical keyboard order, clear focus and readable labels. Preserve the learner-reading approach for the expanded content. |
| M1.S077.01 | Visual direction: Show the Combined Phases explanation within the same interaction. On-screen text: Combined Phases Some trials combine purposes, such as Phase I/II or Phase II/III. Read the actual research question rather than treating the label as the whole explanation. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Combined Phases to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S077.02 | Visual direction: Show the Phase 0 Studies explanation within the same interaction. On-screen text: Phase 0 Studies Some programmes include a very early exploratory study. Phase 0 is not a compulsory step in every programme. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Phase 0 Studies to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S077.03 | Visual direction: Show the Pausing or Revising a Programme explanation within the same interaction. On-screen text: Pausing or Revising a Programme A programme can pause, change or end. Moving to another phase is a decision informed by evidence, not an automatic promotion. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Pausing or Revising a Programme to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S077.04 | Visual direction: Show the Different Types of Interventions explanation within the same interaction. On-screen text: Different Types of Interventions This course focuses on medicine trials. Devices and other interventions do not always use the same phase labels. | Narration: Not applicable On-screen instruction: Read the selected explanation. | Select Different Types of Interventions to expand its explanation. Select it again to collapse the panel. | Keep this content available as text; do not add narration that reads the expanded content. |
| M1.S078 | Visual direction: Use the evidence infographic at a readable width, with the related teaching text close by. On-screen text: Image alternative text: Four main phase questions. Phase I: tolerability, dose and behaviour. Phase II: early benefit and refinement. Phase III: larger-scale benefit and risk. Phase IV: further questions after authorisation. Safety evidence develops throughout. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Provide equivalent alternative text: Four main phase questions. Phase I: tolerability, dose and behaviour. Phase II: early benefit and refinement. Phase III: larger-scale benefit and risk. Phase IV: further questions after authorisation. Safety evidence develops throughout. |
| M1.S079 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Four questions. One developing evidence picture. Phase labels are a helpful starting point, but real-world trials often follow more complex paths. To interpret results accurately, always look at the main research question and the study’s design, not just the phase name. This approach helps you understand what the evidence truly means and how it fits into the bigger picture. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S080 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Safety evidence develops throughout the programme. Identify the purpose and context first. Participant numbers are supporting clues, not fixed boundaries. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S081 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: This guide provides a comparison of the key purposes for each phase of clinical trials, helping you understand the distinct goals at every stage of medicine development. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S082 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Optional Phase 0: a very early exploratory study in some programmes. 2. Phase I: How is it tolerated, what doses can be explored and what happens in the body? 3. Phase II: Is there an early treatment signal in people with the condition, and how should later studies be refined? 4. Phase III: What does larger-scale evaluation show about benefit and risk? 5. Phase IV: What more can be learned after authorisation? | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S083 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Match Study Purpose to Phase | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S084 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Match Study Purpose to Phase” - introduces the sorting activity below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Match study purpose to phase. Read each study purpose on screen and sort it into the correct clinical trial phase. Use the comparison guide above if you need help. Identify phases based on the main research question, not just labels or participant numbers. Use the activity’s category controls or drag the cards. If an item needs another attempt, use the guide and try again. Safety is considered throughout the clinical trial process, and phases may overlap or combine. Always focus on the study’s main purpose. On-screen instruction: Listen to “Match Study Purpose to Phase” - introduces the sorting activity below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S085 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Review the study purposes below and sort each one into the correct clinical trial phase. Use the comparison guide above if you need help. This activity will help you practise identifying phases based on the main research question, not just labels or participant numbers. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S086 | Visual direction: Show one study-purpose card at a time above four clearly labelled phase categories. On-screen text: Categories: Phase I; Phase II; Phase III; Phase IV Cards: Explore initial tolerability and behaviour in the body. Explore early treatment benefit and refine later studies. Evaluate treatment benefit and risk in a larger comparative study before a possible submission. Investigate a further research question after authorisation. | Narration: Not applicable On-screen instruction: Sort each study purpose into its phase. Use the comparison guide if needed. | Drag a card to a category or select a category button. A correct placement advances to the next card; an incorrect placement returns for another attempt. Complete all four cards, then replay the activity if needed. | Accept these matches: Explore initial tolerability and behaviour in the body. → Phase I; Explore early treatment benefit and refine later studies. → Phase II; Evaluate treatment benefit and risk in a larger comparative study before a possible submission. → Phase III; Investigate a further research question after authorisation. → Phase IV. Keep keyboard category selection available. |
| M1.S087 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Safety is considered throughout the clinical trial process, and phases may overlap or combine. Always focus on the study’s main purpose. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
Lesson 5: Put the phases into practice
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S088 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Applying Phase Knowledge in Real-World Communication | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S089 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Applying Phase Knowledge in Real-World Communication” - narrates the introduction and objectives below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Applying phase knowledge in real-world communication. You are helping Morgan prepare the C T one hundred and one project briefing. Three updates are waiting for review. Each sounds plausible; only one in each set keeps the evidence and its limits clear. First, follow the worked example. Then choose Morgan’s wording and use the feedback to revise any overstatement. All programme details are fictional. In this lesson, apply your understanding of clinical trial phases to real workplace situations. Identify phase and purpose in scenarios. Choose accurate update wording. Communicate trial progress with confidence. Select Continue to review the example. Listening is optional throughout. On-screen instruction: Listen to “Applying Phase Knowledge in Real-World Communication” - narrates the introduction and objectives below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S090 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: You are helping Morgan prepare the CT-101 project briefing. Three updates are waiting for review. Each sounds plausible; only one in each set keeps the evidence and its limits clear. First, follow the worked example. Then choose Morgan’s wording and use the feedback to revise any overstatement. All programme details are fictional. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S091 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In this lesson, you’ll focus on applying your understanding of clinical trial phases to real workplace situations. The following objectives will guide your learning: | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S092 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Identify phase and purpose in scenarios 2. Choose accurate update wording 3. Communicate trial progress with confidence | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S093 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S094 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Morgan Reviews an Internal Update | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S095 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Morgan Reviews an Internal Update” - narrates the worked example and introduces the briefing activity below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Morgan reviews an internal update. Morgan receives this fictional note: C T one hundred and one will be studied in people with the condition to explore an initial symptom benefit and refine the dose for a later trial. Morgan first asks what the study is trying to learn. Early benefit and refinement point mainly to phase two. An accurate internal update is: The phase two study will investigate an early treatment effect and gather further safety information. Results will inform the next development decision. This describes the purpose without promising success or authorisation. Use the same method for the next three decisions: identify the purpose, identify the evidence and keep the remaining uncertainty visible. Accurate updates begin by stating the study’s purpose, describing the supporting evidence, and acknowledging any remaining uncertainties. Select Continue to enter the briefing room. Read Morgan’s question and the available statements at each decision. Choose the wording that fits the evidence. Read the coaching feedback, revise any overstatement and continue. All programme details are fictional. On-screen instruction: Listen to “Morgan Reviews an Internal Update” - narrates the worked example and introduces the briefing activity below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S096 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Morgan receives this fictional note: “CT-101 will be studied in people with the condition to explore an initial symptom benefit and refine the dose for a later trial.” Morgan first asks what the study is trying to learn. Early benefit and refinement point mainly to Phase II. An accurate internal update is: “The Phase II study will investigate an early treatment effect and gather further safety information. Results will inform the next development decision.” This describes the purpose without promising success or authorisation. Use the same method for the next three decisions: identify the purpose, identify the evidence and keep the remaining uncertainty visible. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S097 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Accurate updates begin by stating the study’s purpose, describing the supporting evidence, and acknowledging any remaining uncertainties. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S098 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S099 | Visual direction: Use a navy briefing-room backdrop with readable dialogue panels and choices beneath. Keep the fictional coordinator represented through the text. On-screen text: The CT-101 briefing room Controls: START; CONTINUE; TRY AGAIN. | Narration: Not applicable On-screen instruction: Choose the most accurate wording at each decision. Use the feedback to revise an inaccurate line. | Start the briefing and work through three decisions. Accurate choices progress; inaccurate choices display coaching feedback and allow another attempt. Continue to the briefing summary and the debrief. | Present all essential information in text. Keep the setting and study details fictional. Do not narrate the answer choices or conditional feedback. |
| M1.S099.01 | Visual direction: Use the briefing backdrop with a readable text panel and choices beneath it. On-screen text: The CT-101 briefing room Morgan’s update is due. Help the new project coordinator choose three accurate statements. If a line overstates the evidence, use the coaching feedback and revise it. All details are fictional. Choose the most accurate wording at each decision. | Narration: Not applicable On-screen instruction: Select CONTINUE to proceed. | Select CONTINUE to begin the first decision. | Keep dialogue and choices readable without audio. |
| M1.S099.02 | Visual direction: Use the briefing backdrop with a readable text panel and choices beneath it. On-screen text: Morgan: A Phase II report contains encouraging results from the planned symptom measure. Which line should I put in the update? Choices: CT-101 is ready for routine patient use. The findings support further investigation; they do not by themselves establish readiness for routine use. CT-101 has no important safety risks. | Narration: Not applicable On-screen instruction: Choose the most accurate wording. | Select a response to display its coaching feedback. | Keep dialogue and choices readable without audio. |
| M1.S099.03 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Encouraging early findings do not establish readiness for routine use. Revise the line to reflect the evidence and remaining work. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “CT-101 is ready for routine patient use.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.04 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: This wording recognises the encouraging signal while preserving the limits of the evidence. | Narration: Not applicable On-screen instruction: Select CONTINUE. | After selecting “The findings support further investigation; they do not by themselves establish readiness for routine use.”, show this feedback. Select CONTINUE to progress to the next decision or briefing summary. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.05 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: No trial phase establishes the absence of all important risks. Safety evidence continues to develop. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “CT-101 has no important safety risks.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.06 | Visual direction: Use the briefing backdrop with a readable text panel and choices beneath it. On-screen text: Morgan: A larger comparative Phase III study has finished. The team is preparing a submission. Which update is accurate? Choices: Phase III completion means the medicine is authorised. Authorisation is guaranteed because the study was large. The study contributes evidence for regulatory review; authorisation is a separate decision. | Narration: Not applicable On-screen instruction: Choose the most accurate wording. | Select a response to display its coaching feedback. | Keep dialogue and choices readable without audio. |
| M1.S099.07 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Completion is a study milestone. It does not grant permission to market the medicine. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “Phase III completion means the medicine is authorised.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.08 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Study size cannot guarantee an authorisation decision. Authorities assess the submitted evidence for the proposed use. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “Authorisation is guaranteed because the study was large.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.09 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Correct. This separates the evidence milestone from the authorisation decision. | Narration: Not applicable On-screen instruction: Select CONTINUE. | After selecting “The study contributes evidence for regulatory review; authorisation is a separate decision.”, show this feedback. Select CONTINUE to progress to the next decision or briefing summary. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.10 | Visual direction: Use the briefing backdrop with a readable text panel and choices beneath it. On-screen text: Morgan: CT-101 is now authorised in our fictional programme. A formal trial is investigating a longer-term question. Which update is accurate? Choices: A Phase IV study will add evidence about an unresolved question after authorisation. We have restarted Phase I because learning continues. All future safety reports are part of this Phase IV trial. | Narration: Not applicable On-screen instruction: Choose the most accurate wording. | Select a response to display its coaching feedback. | Keep dialogue and choices readable without audio. |
| M1.S099.11 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Correct. This describes the trial’s post-authorisation context without confusing it with all ongoing safety activity. | Narration: Not applicable On-screen instruction: Select CONTINUE. | After selecting “A Phase IV study will add evidence about an unresolved question after authorisation.”, show this feedback. Select CONTINUE to progress to the next decision or briefing summary. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.12 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Ongoing learning does not automatically mean returning to Phase I. The study context here is post-authorisation. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “We have restarted Phase I because learning continues.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.13 | Visual direction: Show coaching feedback over the same briefing backdrop. On-screen text: Routine safety reporting and other monitoring can happen outside a formal Phase IV trial. | Narration: Not applicable On-screen instruction: Select TRY AGAIN. | After selecting “All future safety reports are part of this Phase IV trial.”, show this feedback. Select TRY AGAIN to return to the current decision and revise your choice. | Keep feedback tied to the selected response; do not narrate conditional feedback. |
| M1.S099.14 | Visual direction: Use the briefing backdrop with a readable text panel and choices beneath it. On-screen text: Briefing ready You have kept the evidence and its limits visible across all three updates. Use the same check at work: What is the study trying to learn? What can the evidence establish? What remains uncertain? | Narration: Not applicable On-screen instruction: Select CONTINUE to proceed. | Select CONTINUE to finish the briefing and return to the lesson debrief. | Keep dialogue and choices readable without audio. |
| M1.S100 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Briefing debrief and reflection | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S101 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Briefing debrief and reflection” - narrates the debrief below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Briefing debrief and reflection. After completing the three decisions, use the same check at work: What is the study trying to learn? What can the evidence establish? What remains uncertain? By practising these scenarios, you have learned how to apply phase knowledge to real communications. Identifying the study’s purpose, describing the evidence, and acknowledging uncertainty helps ensure your updates are accurate and useful. This approach builds trust and supports better decisions throughout your organisation. Clear, accurate communication about trial evidence supports responsible decision-making across your organisation. On-screen instruction: Listen to “Briefing debrief and reflection” - narrates the debrief below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S102 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: By practising these scenarios, you’ve learned how to apply phase knowledge to real communications. Each decision you make (identifying the study’s purpose, describing the evidence, and acknowledging uncertainty) helps ensure your updates are both accurate and useful. This approach builds trust and supports better decisions throughout your organisation. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S103 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Clear, accurate communication about trial evidence supports responsible decision-making across your organisation. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
Lesson 6: Check and keep the essentials
| Section | Visual Description & On-Screen Text | Audio Narration / On-Screen Instruction | Action | Notes for Developer |
|---|---|---|---|---|
| M1.S104 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Check and keep the essentials | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S105 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Check and keep the essentials” - narrates the introduction and objectives below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Check and keep the essentials. Check the four main phase questions, then keep the one-page guide for future reference. Use the evidence guide if you need it and retry any question. These checks support introductory learning. They do not assess clinical competence or replace local training, procedures or specialist advice. In this lesson, confirm your understanding and prepare for real-world application. Accurately classify clinical trial examples by phase and purpose. Review how safety evidence develops throughout all trial phases. Reflect on core distinctions and access resources for continued learning. Select Continue when you are ready. All listening is optional. On-screen instruction: Listen to “Check and keep the essentials” - narrates the introduction and objectives below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S106 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Check the four main phase questions, then keep the one-page guide for future reference. Use the evidence guide if you need it and retry any question. These checks support introductory learning. They do not assess clinical competence or replace local training, procedures or specialist advice. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S107 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: In this lesson, you’ll focus on confirming your understanding and preparing for real-world application. Here’s what you’ll be able to do by the end: | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S108 | Visual direction: Show an aligned numbered list with teal number markers and readable text. On-screen text: 1. Accurately classify clinical trial examples by phase and purpose. 2. Review how safety evidence develops throughout all trial phases. 3. Reflect on core distinctions and access resources for continued learning. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S109 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S110 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Four phase checks | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S111 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Four phase checks” - introduces the four questions below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Four phase checks. Read each trial description and choose the phase that best fits its purpose and context. You can use the evidence guide. Select Submit, read the feedback and retry if needed. Work through all four checks on screen. When ready, select Continue to move to the safety check. On-screen instruction: Listen to “Four phase checks” - introduces the four questions below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S112 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: A closely monitored study primarily investigates initial tolerability, dose and behaviour in the human body. Which phase best fits? Choices: Phase I Phase II Phase III Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S112.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase I is the best fit for this early purpose. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase I” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S112.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Revisit the main question. Initial tolerability, dose and behaviour in the body point mainly to Phase I. Safety is also investigated later, but that does not change this study’s primary purpose. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S112.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Revisit the main question. Initial tolerability, dose and behaviour in the body point mainly to Phase I. Safety is also investigated later, but that does not change this study’s primary purpose. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase III” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S112.04 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Revisit the main question. Initial tolerability, dose and behaviour in the body point mainly to Phase I. Safety is also investigated later, but that does not change this study’s primary purpose. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S113 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: A study in people with the condition explores an early treatment effect and helps refine a later study. Which phase best fits? Choices: Phase I Phase II Phase III Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S113.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: The defining clues are an early treatment effect in the target patient group and preparation for later studies. Revisit Phase II. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase I” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S113.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase II is the best fit for early benefit and study refinement. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S113.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: The defining clues are an early treatment effect in the target patient group and preparation for later studies. Revisit Phase II. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase III” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S113.04 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: The defining clues are an early treatment effect in the target patient group and preparation for later studies. Revisit Phase II. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S114 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: A larger study evaluates benefit and risk against an appropriate comparator before a possible authorisation submission. Which phase best fits? Choices: Phase I Phase II Phase III Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S114.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Look at the combination of larger-scale comparative evaluation and the pre-authorisation context. Revisit Phase III. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase I” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S114.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Look at the combination of larger-scale comparative evaluation and the pre-authorisation context. Revisit Phase III. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S114.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase III best fits this larger-scale evaluation before a possible submission. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase III” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S114.04 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Look at the combination of larger-scale comparative evaluation and the pre-authorisation context. Revisit Phase III. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S115 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: After authorisation, a formal trial examines an unresolved question about longer-term use. Which phase best fits? Choices: Phase I Phase II Phase III Phase IV Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S115.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Authorisation has already occurred. Revisit Phase IV, and remember that not all later monitoring is a trial. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase I” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S115.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Authorisation has already occurred. Revisit Phase IV, and remember that not all later monitoring is a trial. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase II” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S115.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Authorisation has already occurred. Revisit Phase IV, and remember that not all later monitoring is a trial. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase III” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S115.04 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase IV is the best fit for a formal post-authorisation trial. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “Phase IV” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S116 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S117 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Safety evidence and essentials | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S118 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Safety evidence and essentials” for the question instructions. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Safety evidence and essentials. Read the safety question and the answer choices on screen. Select an answer and Submit, then use the feedback to review your reasoning. On-screen instruction: Listen to “Safety evidence and essentials” for the question instructions. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S119 | Visual direction: Show the question above a vertical list of selectable answers and a Submit button. On-screen text: Which statement best describes safety evidence? Choices: It is complete at the end of Phase I. It develops throughout the phases and continues after authorisation. It matters only if a medicine does not work. Control: SUBMIT | Narration: Not applicable On-screen instruction: Select one answer, then SUBMIT. Review feedback and retry when needed. | Select an answer and submit it to see feedback for that choice. Use Take Again to retry, or continue reading after reviewing the feedback. | Keep all answer-specific feedback. These introductory checks do not certify clinical competence or prevent reading progression. |
| M1.S119.01 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Phase I begins important safety learning, but it cannot identify every risk. Later studies and monitoring add evidence. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “It is complete at the end of Phase I.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S119.02 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Correct. The safety picture develops as more evidence is gathered. Authorisation does not end learning. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “It develops throughout the phases and continues after authorisation.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as correct. Keep feedback available for learner reading. |
| M1.S119.03 | Visual direction: Show a clear feedback panel beneath the submitted question. On-screen text: Benefits and risks both matter. Evidence of benefit does not remove the need to investigate safety. Control: TAKE AGAIN | Narration: Not applicable On-screen instruction: Review the feedback; select TAKE AGAIN if you wish to retry. | After selecting “It matters only if a medicine does not work.” and submitting, show this feedback. Select TAKE AGAIN to return to the question and choose again. | Treat this response as incorrect. Keep feedback available for learner reading. |
| M1.S120 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue to the essentials Submit your answer to the safety question before continuing. | Narration: Not applicable On-screen instruction: Submit an answer to the safety question, then select Continue to the essentials. | Submit any answer, review its feedback, then select Continue to the essentials to reveal the summary and its separate optional audio. | Keep the summary and second narration hidden until the safety question has been submitted. Do not require correctness or listening. |
| M1.S121 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Start with the question, not the headcount | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S122 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Start with the question, not the headcount” for the safety summary and quick guide below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Start with the question, not the headcount. Safety is considered throughout. No phase guarantees authorisation or removes uncertainty. Quick guide to the essentials. Keep the one-page guide for a quick reminder of the four main questions. Start with the purpose and context; participant numbers are supporting clues. Safety evidence develops throughout, and trial completion does not grant authorisation. read guide using the attachment below. Select Continue when ready for the optional reflection and sources. On-screen instruction: Listen to “Start with the question, not the headcount” for the safety summary and quick guide below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S123 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Start with the question, not the headcount. Safety is considered throughout. No phase guarantees authorisation or removes uncertainty. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S124 | Visual direction: Use the evidence infographic at a readable width, with the related teaching text close by. On-screen text: Image alternative text: Four main phases: I explores tolerability, dose and behaviour in the body; II explores early benefit and study refinement; III evaluates benefit and risk at greater scale; IV investigates further questions after authorisation. Safety evidence develops throughout. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | View the visual; select its zoom control where provided, then close it to return to the same section. | Provide equivalent alternative text: Four main phases: I explores tolerability, dose and behaviour in the body; II explores early benefit and study refinement; III evaluates benefit and risk at greater scale; IV investigates further questions after authorisation. Safety evidence develops throughout. |
| M1.S125 | Visual direction: Use a prominent section heading above a short, left-aligned reading panel. On-screen text: Quick Guide to the Essentials Keep the one-page guide for a quick reminder of the four main questions. Start with the purpose and context; participant numbers are supporting clues. Safety evidence develops throughout, and trial completion does not grant authorisation. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S126 | Visual direction: Show a clearly labelled quick-guide read with a document icon and read control. On-screen text: supporting resource | Narration: Not applicable On-screen instruction: read one-page guide for future reference. | Select the read control to save or open the one-page guide, then return to the course. | Provide the actual portable PDF download; keep the course available when the guide opens. |
| M1.S127 | Visual direction: Use a full-width teal Continue button to separate the next group of content. On-screen text: Continue | Narration: Not applicable On-screen instruction: Select Continue to reveal the next section. | Select Continue to reveal the next group of content in the lesson. | Use this as a pacing divider. Do not require listening or answer correctness to continue. |
| M1.S128 | Visual direction: Show a full editable section heading directly above its native narration player. Keep the two close together, with matching content below the player. On-screen text: Reflection and further learning | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S129 | Visual direction: Place a compact optional audio player immediately below its full editable section heading and before the matching text, visual or activity. Keep the listening caption directly beneath the controls. On-screen text: Listen to “Reflection and further learning” - introduces the reflection and resources below. Listening is optional. Controls: Play; Pause; Seek; Play speed; Mute; Volume; Show transcript; Hide transcript. | Narration: Reflection and further learning. Think of an internal update you might need to write. In your own notes, complete these three sentences: This study is investigating, followed by its research purpose. Its results could help establish, followed by what the evidence could show. It would be premature to claim, followed by an overstatement to avoid. Self-check: Did you identify the research purpose? Did you describe the evidence rather than promise success? Did you preserve the remaining uncertainty? This optional reflection stays in your own notes. The course does not collect, save or assess it. Continue building your knowledge. Use the quick guide and explore trusted sources as you encounter clinical trial information in your role. For clinical research responsibilities, continue with your organisation’s role-specific training and current procedures. Read the resource descriptions and open the links that are useful to you. Cancer Research UK examples relate to cancer and may differ from other medicine programmes. FDA and the US clinical study registry use US regulatory terminology; they are not instructions for UK submissions. All case details are fictional. On-screen instruction: Listen to “Reflection and further learning” - introduces the reflection and resources below. Listening is optional. | Select Play to listen, Pause to stop, or keep reading. Adjust playback, speed or volume as needed. Show the transcript to read the script and hide it to return to the section. | Use Caleb Articulate. Start paused, with the transcript closed. Listening must not be required for progression. Preserve the full transcript. Keep expandable panels, choices and conditional feedback for learner reading. |
| M1.S130 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: Think of an internal update you might need to write. In your own notes, complete: This study is investigating ____. Its results could help establish ____. It would be premature to claim ____. Self-check: Did you identify the research purpose? Did you describe the evidence rather than promise success? Did you preserve the remaining uncertainty? This optional reflection stays in your own notes. The course does not collect, save or assess it. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | Keep reflection private and ungraded. The course must not collect, save or assess the learner’s notes. |
| M1.S131 | Visual direction: Use a centred statement with a small teal accent and generous whitespace. On-screen text: Continue building your knowledge. Use the quick guide and explore trusted sources as you encounter clinical trial information in your role. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S132 | Visual direction: Use a left-aligned reading panel with short paragraphs and generous spacing. On-screen text: For clinical research responsibilities, continue with your organisation’s role-specific training and current procedures. Explore the sources below. Cancer Research UK examples relate to cancer and may differ from other medicine programmes. FDA and the US clinical study registry use US regulatory terminology; they are not instructions for UK submissions. All case details are fictional. | Narration: Not applicable On-screen instruction: No separate on-screen instruction. | Read the content, then scroll to continue. | No additional notes. |
| M1.S133 | Visual direction: Stack the source descriptions with clearly labelled buttons leading to the corresponding resource. On-screen text: Source buttons: NHS trials; FDA research; Cancer Research UK; HRA consent; Study glossary; Protocol terms; NIHR study guide | Narration: Not applicable On-screen instruction: Explore the sources for continued learning. | Select a source button to open its resource in another tab. Return to the course tab to continue. | Use the exact destinations shown with the corresponding labels. Retain the nearby UK, US and cancer-context qualifications. |
| M1.S133.01 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: NHS trials A public introduction to clinical trials and participation. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select NHS trials to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.02 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: FDA research Phase purposes, protocols and early clinical research. US context. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select FDA research to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.03 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: Cancer Research UK Phase 0, combined phases and cancer-specific examples. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select Cancer Research UK to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.04 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: HRA consent Information and consent in research participation. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select HRA consent to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.05 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: Study glossary Study terms and phase definitions. US terminology. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select Study glossary to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.06 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: Protocol terms Definitions including allocation and masking. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select Protocol terms to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |
| M1.S133.07 | Visual direction: Pair the source description with its clearly labelled resource button. On-screen text: NIHR study guide Research participation and how studies are organised. the named source | Narration: Not applicable On-screen instruction: Select the source button to explore the resource. | Select NIHR study guide to open the resource in another tab; return to the course tab to continue. | Use the destination shown. Preserve the context qualifications in the surrounding course text. |