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 3 required videos and 1 recommended video. 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. 

Module Objectives
At the conclusion of this module, learners will be able to: 

Required   

Part 1

Overview of Protocol Development, Review and Approval (15 minutes)

Part 1 Handout

Resources

Evaluation

Part 2

Elements of a Protocol (13 minutes)

Part 2 Handout

Part 3

The Who, What, Why and Where of IRB Meetings and Membership (62 minutes – final 12 minutes is Q&A, this is optional)

Part 3 Handout

Recommended  

How Do I Review Thee? Let me Count the Ways: The Types and Manners of IRB Review (47 minutes) Handout