Key Checklists and Worksheets

Many checklists and worksheets for reviewers are available in the IRB Library to provide reminders, guide decisions, and help document decision criteria.

Important! Checklist information is required by regulations to document the findings that justify your determinations. Fill out the pertinent checklists and attach them when you submit the review form. For committee reviews, attach your individual checklists as described in Preparing Comments for a Meeting.

Worksheets also provide important guidance, but regulations do not require them to be retained.

The following table summarizes some of the key pertinent checklists and worksheets, organized by the types of review decisions you must make. Consult with your IRB policies and procedures for a complete list of Checklists, Worksheets and requirements.

 

TopicChecklists
(use and attach)		Worksheets
(for reviewer's use)
Approval criteria
 
Level of review
 
Consent / recruitment
 
Special populations
 
Devices / drugs
 
Federal agencies / laws

Research Administration and Compliance Suite Office Hours (ESTR-IRB, Agreements-DUA, Data Safety, OAIR)

The system support team is available during regular office hours to provide one-on-one time to demonstrate system functions, provide training, answer questions, and collect feedback. Sessions cover the entire suite (ESTR-IRB, Agreements-DUA, Data Safety, and OAIR) and are customized based on the registrant preference. 

Office hours are open:
• Tuesdays: 10:00am ET - 11:00am ET
• Thursdays: 3:00pm ET - 4:00pm ET

Please schedule time with us!
1. Visit the Bookings page (linked here) 
2. Choose a time.  Available times (not already booked) will display for 30-minute increments.
3. Share your name and email
4. Click "Book" at the bottom of the page. 

After completing the steps through Bookings, you will receive a confirmation email/calendar invitation reserving the time.
If you have any questions or concerns, please contact us at estrhelp@harvard.edu.