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:
| 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) |
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| Part 3 |
IRB Membership (16 minutes) |
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| Part 4 |
IRB Registration and Federal Wide Assurance (31 minutes) |
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| Part 5 |
Protocol Review and Approval from the PI Perspective (40 minutes) |
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| Part 6 |
Protecting Vulnerable Subjects (47 minutes) |
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| Recommended | ||||
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Writing a Protocol (48 minutes) | ||||
| Optional | ||||