Primary Reviewer Worksheet – Modification and Continuing Review
This worksheet is for use by the Designated Reviewer (expedited reviews) and the Primary and Secondary Reviewer (convened IRB reviews) when preparing for the review of continuing review and/or modification applications for a study and for non-UW sites that are reviewed by the UW IRB per a reliance agreement. The Primary and Secondary Reviewers use this worksheet, together with the Pre-review Note prepared by HSD Staff, to review the application, identify and write down issues for discussion by the IRB. The Pre-review Note can be found in the Reviews tab of the ZIPLINE application. Filling out this form is not a requirement, but reviewers may wish to take notes on it to use as a guide during the IRB meeting.
Change Notes
Add reference to PAUSE Framework 06.25.2024
Add reference to new Reasonably Foreseeable Risks Guidance – 01.26.2023
Updated hyperlinks – 10.08.2021
Clarify continuing review requirements for prisoner subjects; add guidance about approval period for modifications that trigger the need for continuing review – 08.26.2021
Remove reference to paper and POLICY Regulations – 04.29.2021