CLINICAL CANCER INVESTIGATIONs COMMITTEE (CCIC)

David K. Gaffney, M.D., Ph.D., Chair david.gaffney@hci.utah.edu 801-581-2396	Leigh A. Neumayer, M.D. leigh.neumayer@hsc.utah.edu 801-581-2431
	Mariah Butterfield, Committee Coordinator Mariah.Butterfield@hci.utah.edu 801-585-3958

I. Background and Purpose:

The Clinical Cancer Investigations Committee (CCIC) was formed in 1993 to comply with National Cancer Institute guidelines in establishing a scientific review and monitoring system of cancer studies - it is a mechanism for quality assurance. The CCIC membership includes faculty, statisticians, pharmacy, imaging, patient advocate, research nurse and other ad hoc reviewers 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 in research.

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 doesn't need CCIC review.

II. New Project Submission

For Investigator-Initiated Studies

Investigator-Initiated projects must be submitted, reviewed, and approved by the CCIC prior to IRB submission.

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

For New Cooperative Group

SWOG, CTSU, RTOG, NSABP, COG, ACOSOG, and GOG projects will undergo an expedited CCIC review.

Committee Deadline

The CCIC meets the 4th 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.

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 in ERICA (see below). The study will be administratively reviewed to determine if it is exempt from further review.

Application Process: To submit a study to the CCIC you must complete the ERICA application online:

https://erica.research.utah.edu/erica
Click here for instructions on submitting a new study application.

If the study is designed to include cancer patients, mark "Yes" to question 4.2g of the new study application. Once you have submitted the study, the CCIC will be notified that your study needs Committee 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 reviews. Studies accruing less than 50% of the annual target accrual are carefully evaluated and subject to possible closure by the Committee.

When the yearly project continuing review has been submitted to the IRB via the ERICA website, a review by the Committee will be generated. The continuing review application will be retrieved from ERICA by CCIC staff for review and the PI and IRB notified if issues are identified.

IV. Protocol Modification/Amendments/Final Project Reports

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

All relevant information from these applications will be retrieved from ERICA and reviewed by the CCIC. The PI and IRB will be notified if the Committee identifies issues that need to be addressed.

V. Questions

Contact the CCIC Committee Coordinator, Mariah Butterfield; 801.585.3958.

Updated 9/2/2009