Adverse Event Reporting

Amendment Submissions

New Protocol Submissions

Other Event Reporting

Termination of Protocol
 
 
last updated 4/19/07

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:

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.

Forms

Schedule of Events (Schema) Review
HIPAA Elements to Include in Written Consent
Adverse Event Reporting Policy
Literature search guidelines

If the IRB does not receive renewal documents in time to be reviewed at a committee meeting, the protocol will expire. Investigators must cease cease all activities, including data analysis, on any expired research study.

Alternatively, investigators are encouraged to formally terminate their protocols when study activities are complete. Note that to terminate a study, study activities need only be complete at the University of Chicago. For sponsored studies, investigators do not need to wait until study procedures are finished at all sites in order to close the study at this site. However, investigators should not terminate a study on which they plan to continue working with data. As with expired studies, investigators must cease cease all activities, including data analysis, on any terminated research study.

Forms

Protocol Termination Report                       Version: APRIL 2007               Posted: 4/19/07