Continuing Review Submission

Forms
Guidance

To renew a protocol, a complete renewal package (including the continuing review form and any supplemental materials) must be submitted in time to be reviewed at a convened meeting.  Due to the large volume of protocols, it is recommended that renewal packages be submitted to the IRB at least two months prior to expiration.  To avoid protocol expiration, all materials to be reviewed must be received prior to the expiration date.  If a protocol requiring full review is not reviewed for renewal at a convened meeting, the protocol will expire and thus be terminated.  In order to continue research which has been terminated, investigators must resubmit the entire protocol as a new submission. 

A renewal submission should include:

- a completed, signed continuing review form
- a copy of the current consent formor oral script if future enrollment is anticipated
- any advertisements that will be used
- a copy of the most recent grant progress report (if the study is funded by a grant)
- a copy of the most recent available DMC/DSMB report (if the study uses a DSMB)
- a copy of the most recent approval letter from any other sites at which research supported by the University of Chicago is conducted
- a copy of each questionnaire/survey that will be used that is unique to the study

In addition, IRB staff members or the IRB Committee may request additional forms or information in order to fully review the scope and progress of the research. When filling out the form itself, please keep in mind that reviewers must make a determination on renewal based on the information at hand.  If this information is unavailable or difficult to find, the renewal of your protocol(s) may be delayed. For this reason, the Committee asks that all questions on the continuing review form be addressed for every protocol.

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Forms

Form
Purpose
Version date
Continuing Review Required for all renewal submissions April 2007
Supplemental form C Research involving children March 2007
Supplemental form I Advertising on U of C webpages October 2005
Waiver of Authorization Use of PHI during screening August 2006

 

Guidance

Schedule of Events (Schema) Review

HIPAA Elements to Include in Written Consent

Adverse Event Reporting Policy

Literature search guidelines