WORKSHEET Pre-Review, Initial Application
This worksheet provides support for HSD staff conducting pre-review of initial applications that have not requested External IRB review (including deferral responses and conditional approval responses) by identifying the issues that should be covered as part of the pre-review.
Change Notes
Insert Note To File language for EFIC short form exception; revise day of the week RA team conducts CT.gov assessments; add table listing significant IRB Protocol updates – 01.30.2025
Add guidance for granting HIPAA waivers for UW PHI for NHS or NED applications – 10.31.2024
Add reference to new suicide risk suite of materials – 9.26.2024
Add clarifying statements related to situations when the FDA issues an IND exempt letter – 05.30.2024
Add link to information about cancer-related and Fred Hutch primary PIs; add information about transfers process – 11.02.2023