Clinical Trial Protocol Development and Write-Up
12 Contact Hours - 3 Days
Overview This training introduces attendees to the proper methods of writing clinical trials’ protocols that include the components and regulatory requirements needed for approvals by the IRB/IEC, FDA and competent authorities.
Objectives
Objectives
At the end of the training, participants will:
- Understand the different types of clinical trials, phases, randomization, blinding, and statistical analyses
- Gain knowledge of the regulatory requirements that must be included in every clinical trials’ protocol
- Be able to draft an outline for a clinical trial protocol
- Be able to evaluate an already written clinical trial protocol