January 2009

The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (SKCCC) is an NCI designated Cancer Center.  NCI designated Cancer Centers are required to review the scientific aspects of all cancer-related clinical research being done at the Institution.  The Clinical Research Review Committee (CRC) was established for this purpose.

The CRC is charged with the pre-review of the scientific merit, priorities, and progress of all clinical research involving cancer patients.

In order to ensure compliance with the NCI’s guidelines, the following process is conducted for NEW applications:

1. Section 30 of the eIRB application is the mechanism used to collect information on cancer related research.  When an investigator submits an application and Section 30 is marked as “yes,” the application is automatically routed to the SKCC Clinical Research Office (CRO).  The CRO provides administrative support for the CRC.
2. The CRO will make one of two determinations when an application is received: a)  The application does not require review by the CRC.  In this case, CRO staff will add a comment in the eIRB system and submit the application to the IRB office; or b) The application requires review by the CRC.  The CRO will ensure that the submission is complete and schedule the review. 
3. The CRC may act to approve the application or disapprove the application.  If the application is disapproved, the PI is notified and the eIRB application is not routed to the IRB for review.  If the application is approved, the PI is notified and the application is routed to the IRB office.  The CRC may impose stipulations for the conduct of the protocol, and such stipulations would be provided to the IRB office. 

An application received by the Office of Human Subjects Research may not be marked correctly in Section 30.  If OHSR staff or the IRB should determine that CRC review is required, the application will be returned to the PI for correction.  Once section 30 is completed, the submission process to the CRC will occur.

Process for CRC review of continuing review applications:  In addition to the  review of a new application, the CRC is required to conduct a continuing review of the scientific progress of all therapeutic cancer trials.  The CRC review process occurs at the time of the scheduled IRB continuing review process.  The CRC will provide to the IRB  any significant findings that it believes affects the continued conduct of the study.

The CRC meets weekly to review applications. The CRO staff is located in Room 1101 in the 550 Building and may be reached at (410) 955-8866. They can provide details regarding the CRC’s review requirements and time frame estimates for completing their review. 

For more information please visit the CRO website or call (410) 955-8866.