I. Background and Purpose :

The Clinical Cancer Investigations Committee (CCIC) was formed in 1993 to comply with National Cancer Institute guidelines to establish a scientific review and monitoring system of cancer studies--it is a mechanism for quality assurance. It includes 15 faculty members from various disciplines within the Health Sciences.

The CCIC reviews cancer-related protocols for scientific merit and progress, including participant accrual. It also prioritizes cancer protocols that may compete for the same patient population. Its function is complementary to that of the Institutional Review Board, which focuses on the protection of human subjects.

If your study is designed to involve cancer patients, it must receive CCIC approval before it can be IRB approved. If your study includes cancer patients by default (as part of a broader patient population) and not by study design, it does not need CCIC review.

II. New Project Submission

1. For New Cooperative Group and Investigator-Initiated Studies

Cooperative group and investigator-initiated projects must be submitted to and reviewed by the CCIC prior to IRB submission. SWOG, RTOG, NSABP, COG, ACOSOG and GOG projects will undergo an expedited CCIC review.

Application Documents: CCIC review requires the documents listed below. Either forward the documents to Tiffany Stanton (tiffany.stanton@hci.utah.edu) or advise Amber that the documents are available on ERICA and she will retrieve them.

2. For New Multi-site, Industry-Sponsored Trials

Multi-site, industry-sponsored trials can be submitted to the CCIC and IRB simultaneously, although the IRB will not provide final approval until the CCIC has approved the project.

The documents listed above are required for CCIC review. Either forward the documents to Tiffany Stanton (tiffany.stanton@hci.utah.edu) or advise Amber that the documents are available on ERICA and she will retrieve them.

3. Deadline: The Committee meets the 4 th Thursday of each month. Applications are due by noon the 7th of each month. If the deadline falls on a weekend, the submission is due the preceding Friday

4. Exemption from Full-Board CCIC Review

If your study is a non-therapeutic retrospective study (i.e., chart review or database or tissue review only with no patient contact), it may be exempt from full-board CCIC review. Please submit the new application documents listed above to Tiffany Stanton (tiffany.stanton@hci.utah.edu). The study will be administratively reviewed to determine if it is exempt from further review.

III. Annual Review of Projects

Protocols must be reviewed annually by the CCIC until final closure. The National Cancer Institute mandates regular review of project scientific progress, including accrual review. Studies accruing at less than 50% of the annual target accrual are carefully reevaluated and subject to possible closure by the Committee.

When the yearly project renewal has been submitted to the IRB via the ERICA website, notify Tiffany Stanton (tiffany.stanton@hci.utah.edu). The renewal application will be retrieved from ERICA by CCIC staff for review and the PI and IRB notified if issues are identified.

IV. Protocol Modifications/Amendments/Renewals/Internal Adverse Events/Closures

All study changes must be submitted to and reviewed by CCIC for potential impact on study design or progress. Study changes include amendments, renewals (see Section III above), internal SAEs, and final reports.

Notify Tiffany Stanton (tiffany.stanton@hci.utah.edu) of these changes after the information has been submitted to the IRB through ERICA, noting in the email the type of change that has been submitted (e.g. amendment, internal SAE, final report). The relevant information will be retrieved from ERICA and reviewed by the CCIC. The PI and IRB will be notified if the Committee identifies issues to be addressed.

V. Questions

Tiffany Stanton , CCIC Committee Coordinator, tiffany.stanton@hci.utah.edu; 587-4670

Jennifer Katz , CCIC Administrative Director, jennifer.katz@hci.utah.edu ; 585-5017

7/3/08