*IRB Protocol
This form is used in conjunction with Zipline to submit an application to the IRB. If you anticipate that you will have no contact with subjects, such as with a medical records review, use the form: APPLICATION IRB Protocol, No Contact with Subjects.
The form must be submitted as a Word document (not PDF or other format).
Change Notes
Revise FDA Part 11 compliance statement to note that UW ITHS REDCap is not compliant – 03.27.2025
Remove question asking about legal validity of using REDCap outside of WA state; make 5.10 a required question; make reasonably foreseeable risks its own subquestion of 10.1 – 02.27.2025
Update FDA Part 11 compliance statement for UW ITHS REDCap; add question about Short Form Consent – 12.23.2024
Update reference for retired SOP Use of the UW IRB – 11.26.2024
Add reference to new suicide risk mitigation plan supplement – 09.26.2024