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
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
Revise UW Medicine policy on using eCare/MyChart for research recruitment; update references to revised FDA suite – 08.31.2023
Remove reference to retired SOP LIRB and WORKSHEET Identifying the Applicable Regulations; revise instructions for FDA question in Study Scope SmartForm – 07.27.2023