• Clinical trial phase
Design a phase 3 clinical trial that would support your case for registration (e.g., cross-over, comparator, case-control/cohort). Identify the merits of this design.
• Clinical trial elements
For your trial, briefly describe the how you will find your target population, the number of participants, your inclusion and exclusion criteria, the measurements taken and the endpoints.
• Clinical trial management
Explain how you would you ensure that your trial complied with GCP guidelines? Are there any ethical concerns that need to be addressed?
• Clinical trial regulations
Give an overview of the approval process for a clinical trial proposal and the documentation that would be needed for the clinical trial to run once authorised.
