Institutional Review Board (IRB) CONTENT Package

Includes a reference article, powerpoint training presentation, and instructional trainer notes:

➢ 1.Meeting FDA Institutional Review Board Requirements: An Auditor's Viewpoint (Reference Article)

➢ 2. and 3. Institutional Review Board Requirements: A Regulatory Overview (PDF PowerPoint Presentation and Instructional Trainer Notes)

1.Meeting FDA Institutional Review Board Requirements: An Auditors Viewpoint (Reference Article)

The number of Warning Letters FDA is issuing related to IRB violations is increasing. This article review IRB requirements from an auditor's viewpoint; and provides information to help you determine whether an IRB is effectively fulfilling their roles and responsibilities throughout the clinical trial research process and meeting FDA requirements. Topics include:

➢ Regulatory basis for IRBs

➢ Why are they necessary

➢ Roles and responsibilities of the IRB

- IRB composition

- Written Procedures

- Records and Reports

- Expedited review

- Local vs. central IRBs

➢ Role of the IRB during the clinical trial process

- Relationship between the sponsor, clinical investigator site and IRBs

- Administration of the informed consent

- Clinical trial control documents required to be reviewed by the IRB

- Continuing review

- Informed consent process

- Subject comprehension of informed consent

➢ FDA inspections of IRBs

- Sponsor viewpoint

- Effective communication

- Tracking studies

- Excerpts of Warning Letters resulting from an FDA inspection of an IRB

2. and 3. Institutional Review Board Requirements: A Regulatory Overview (PDF PowerPoint Presentation and Instructional Trainer Notes)

➢ 10+ slide PDf PowerPoint Training Presentation based on the subject matter presented in reference content article above. This PDF readymade presentation provides "core" subject matter content, and allows you to customize specific information within your presentation. Trainer instructional notes, which contain 20+ discussion points related to the PowerPoint training presentation, are also included. Trainer instructional notes are designed to help focus your presentation on key points, engage attendees and encourage their participation in your training.

IRB CONTENT Package is only $99.00