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Transcript

This simulation should take you just over two hours, and is divided into the following sections:

  • A preparation task, which should take you up to 15 minutes
  • A 30 minute research task
  • A 30 minute analysis task
  • A 30 minute create task
  • A 10 minute document and presentation activity
  • And finally, a reflection task, which should take you around 10 minutes.

NEXT

Materials Needed

Computer with internet access

Journal articles and clinical guidelines

Document editing software

Spreadsheet software

(e.g. Microsoft Word, Google Docs)

(e.g. Microsoft Excel, Google Sheets)

Presentation software

(e.g. PowerPoint, Google Slides)

Preparation Task (10 minutes)

Research Task (30 minutes)

Analysis Task (30 minutes)

Create Task (40 minutes)

As a reminder, below are the steps we're going to take in order to complete the simulation. There will be timers on each step, but this is simply there for guidance and there is no pressure to finish before or after the time is up!

If you're ready, click the 'Next' button below to get going!

Document and Present (20 minutes)

Reflection Task (10 minutes)

Expected Outcome

Simulation

Simulation

PREPARAtion task

Preparation Task

Understand the key components of a clinical trial and the role of a Clinical Research Practitioner.Read an Article: Read a brief article or watch a video that covers the basics of clinical trials and the responsibilities of a clinical research practitioner.

Read article: "Introduction to Clinical Trials"

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

Simulation

research task

Identify relevant literature and guidelines to inform the design of a clinical trial.

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

Market Reports

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

Search for and review at least three journal articles or clinical guidelines related to a hypothetical clinical condition (e.g., a novel treatment for Type 2 Diabetes).

Literature Review

Identify and make note of the key guidelines that will inform your clinical trial design.

Guideline Identification

Simulation

Analysis Task

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

Analyse the gathered information to outline the trial protocol components.

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

Market Reports

Search for recent market reports, articles, or statistics related to your chosen market segment. Use sources like Statista, Nielsen, or industry-specific publications.

List the components needed for your clinical trial protocol (e.g., hypothesis, objectives, methodology, inclusion/exclusion criteria, outcome measures, ethical considerations).

Trial Components Identification

Use a spreadsheet to organise the key information and data points that will be required for each component.

Data Organisation

Simulation

Create Task

Develop a detailed clinical trial protocol based on the analysed data and guidelines.

Protocol CreationCreate a detailed clinical trial protocol document. Include sections for the following: - Title - Abstract - Background and Rationale - Study Objectives - Study Design and Methods - Population and Sample Size - Ethical Considerations - Data Management and Analysis Plan

Incorporate GuidelinesEnsure that all aspects of the protocol adhere to the clinical guidelines identified during the research phase.

Simulation

Document and Present

Compile Documentation

Use presentation software to compile the critical elements of your trial protocol into a concise and visually appealing presentation.

Presentation

Present your protocol to a peer, mentor, or supervisor via a video conferencing tool or share it through a digital platform for feedback.

Consolidate the protocol and present it for feedback.

Simulation

Reflection Task

Reflect

Future Application

Reflect on the process and identify areas for improvement.

Spend 10 minutes writing a reflection on the process. Consider what went well, what challenged you, and what you could improve next time.

Think about how the skills and knowledge gained can be applied to future clinical research projects. Identify any additional skills or knowledge areas you need to develop.

Simulation

Expected outcome

By the end of this activity, you will have developed a detailed clinical trial protocol based on thorough research and guideline review. This exercise will enhance your understanding of the clinical trial design process, improve your ability to compile and organise clinical data, and provide hands-on experience in creating critical clinical trial documentation.

Expected Outcome