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Application Process for New Studies
1. PI/CRA Submits application via e-mail
Signatures are not required at this point.
Please refer to the IRB New Application Submission Checklist for PIs/CRAs (PDF).
2. PI/CRA receives notification of receipt of application
Once the application is received, a notification will be sent to the PI and CRA with the IRB file number and analyst contact information.
3. Analyst conducts pre-review
The analyst will conduct a pre-review to check for completeness and compliance.
To see what the analyst will be looking for during pre-review, please see the Regulatory Analyst IRB New Application Pre-Review Checklist (PDF).
Once the pre-review is complete, a memo will be sent to you with suggestions to improve the application.
4. PI/CRA receives pre-review suggestions
The PI/CRA will review the suggestions and make the appropriate changes. We urge you to contact the analyst with any questions you might have.
Analysts are willing to meet with you in person to discuss the pre-review.
5. PI submits final application
Once changes are made, please e-mail the final application to the general IRB e-mail address.
Signatures are not required at this point; however, the application MUST be submitted from the PI's e-mail address. Please include the word "Final" in the file name.
6. PI/CRA receives notification of final submission
Once the final application submission is received, a notification will be sent to the PI and CRA.
7. PI/CRA receives notification of IRB meeting
Once the application is put on an IRB agenda, notification of the date, time and location of the meeting will be sent to the PI and CRA.
8. PI attends IRB meeting (optional)
While attending this meeting is optional, we encourage attendance as it facilitates the IRB review and approval process.
If you are unable to physically attend, we can arrange for a teleconference.
9. If there are no contingencies
You will be asked to submit a signed hard copy of application. The IRB Chair will sign the application.
The approved application, approval letter and PI Responsibility Memo (PDF) will be sent to you. The study may then begin.
10. If there are contingencies
A contingency letter will be drafted and sent to you. Please feel free to contact us and arrange a meeting for clarification/discussion of the contingencies.
11. PI/CRA makes changes per contingencies
Any necessary changes are made to the application and a memo is drafted outlining the changes that were made to the application.
The memo of changes and updated application should be e-mailed to the analyst assigned to your study.
12. Analyst and IRB Chair review and send PI/CRA notification
The analyst and IRB Chair will review the application to ensure contingencies were met.
Once contingencies are met, the analyst will notify you and ask you to submit a signed hard copy of application.
13. PI signs and submits hard copy of application
Submit a signed hard copy of application to the IRB at mailstop MPW 5-1.
14. The IRB Chair signs the application
Once received from the PI, the IRB Chair will sign the application as approved.
15. PI/CRA receives approval
The approved application, approval letter and PI Responsibility Memo (PDF) will be sent to the PI/CRA. The study may then begin.