Submitting a Social and Behavioral Research Continuing Review

1. Navigate to the Forms page (1) and click on Social and Behavioral Research Forms, Continuing Review (2).

2. A Continuing Review submission has three or more components including a cover letter for the submission (1).

3. A Continuing Review submission also includes a copy of the completed Continuing Review Facepages (2), and a copy of the completed Continuing Review Narrative Summary of Progress (3), which can be obtained from the HRPP website.

4. The Continuing Review Facepages include an outline of the documents that need to be submitted for Continuing Review.

5. The completed Narrative Summary of Progress to Date must provide a response to each item requested. As noted on the Narrative, if a numbered section does not apply to the study, enter "N/A" or "Not Applicable" in the white space below the numbered header.

6. A copy of the IRB-stamped approved consent(s)/assent(s) currently in use by the project must be provided, if the study is obtaining documented consent/assent. Do not send a consent/assent that has been signed by a study participant.

7. A "clean" copy of the consent/assent form, as a Word document, must also be submitted for "restamping."

8. Associated study documentation must also be submitted including a copy of any site monitoring forms, progress reports, audits, communications to/from the FDA and/or publications associated with the project, as applicable, since the last IRB review (initial or continuing).

9. Once you have your Continuing Review documents ready to upload, click on "My Protocols at a Glance" after you have logged in through e-IRB services.

10. Click on the project number link to which you would like to upload Continuing Review documents.

11. Click on the "Upload document(s) for continuing review" link.

12. Begin uploading your documents following the four steps outlined on the "Upload Document Files" page.