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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. 

 Module Objectives
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).
Required   
Part 1 Overview of Protocol Development, Review and Approval (12 minutes)
Note: may take a few minutes to open.
Part 1 Handout Resources Evaluation
Part 2 Elements of a Protocol (22 minutes)

 

Part 3

IRB Membership (16 minutes)

 
Part 4

IRB Registration and Federal Wide Assurance (31 minutes)

 
Part 5

Protocol Review and Approval from the PI Perspective (40 minutes)
Note: video includes other information related to working with the IRB

 
Part 6

Protecting Vulnerable Subjects (47 minutes)

 
Recommended   

Writing a Protocol (48 minutes)
Office for Human Subject Protection: IRB Records Part One (6 minutes); IRB Records Part Two (14 minutes)
Local and Central IRB Relationships: Individual and Shared Responsibilities (43 minutes)
Nuts and Bolts of 45 Part 46 (65 minutes)

Optional

Research Involving Vulnerable Populations (28 minute)

Last updated by Ness, Elizabeth (NIH/NCI) [E] on Aug 19, 2016