Clinical Research Operations

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: 

• Describe the basic elements of a protocol.
• Identify 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).