Protocol Development, Review and Approval
The clinical trial protocol is the heart of any research project, It is a “recipe” for ensuring that the procedures/measures outlined in the research study are carried out in a consistent, reproducible manner. Once a protocol is written but before it can be initiated, the protocol must go through a review and approval process. This includes scientific, safety, and ethical reviews. The module is divided into 6 required components (videos) and 2 recommended videos. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
At the conclusion of this module, learners will be able to:
- Describe the basic elements of a protocol.
- Describe the types of review that a protocol may go through before it can be initiated.
- Discuss the roles and responsibilities of the institutional review board (IRB).
|Part 1|| (12 minutes) val
Note: may take a few minutes to open.
|Part 1 Handout||Resources||Evaluation|
|Part 2||Elements of a Protocol (22 minutes)||
IRB Membership (16 minutes)
IRB Registration and Federal Wide Assurance (31 minutes)
Protocol Review and Approval from the PI Perspective (40 minutes)
Protecting Vulnerable Subjects (47 minutes)
Writing a Protocol (48 minutes)