Clinical trial design and regulations

• Clin" rel="nofollow">inical trial phase Design a phase 3 clin" rel="nofollow">inical trial that would support your case for registration (e.g., cross-over, comparator, case-control/cohort). Identify the merits of this design. • Clin" rel="nofollow">inical trial elements For your trial, briefly describe the how you will fin" rel="nofollow">ind your target population, the number of participants, your in" rel="nofollow">inclusion and exclusion criteria, the measurements taken and the endpoin" rel="nofollow">ints. • Clin" rel="nofollow">inical trial management Explain" rel="nofollow">in how you would you ensure that your trial complied with GCP guidelin" rel="nofollow">ines? Are there any ethical concerns that need to be addressed? • Clin" rel="nofollow">inical trial regulations Give an overview of the approval process for a clin" rel="nofollow">inical trial proposal and the documentation that would be needed for the clin" rel="nofollow">inical trial to run once authorised.