Instructions for Submitting Clinical Trial Materials to the PRC
UNC Lineberger the Largest Team for Fourth Straight Year

The Protocol Review Committee (PRC) is a multidisciplinary standing Committee of the UNC/Lineberger Comprehensive Cancer Center (UNC/LCCC) and the UNC Clinical Cancer Program; a joint entity of the UNC/LCCC, UNC Hospitals and the UNC School of Medicine. The PRC’s responsibility is the peer review of local and national research protocols involving cancer patients PRIOR to submission of the protocol to the UNC Institutional Review Board (IRB).

*UPDATED* The PRC reviews any protocol which involves interaction with the UNC cancer population, regardless of whether it qualifies for expedited IRB review or requests for IRB exemption.

Retrospective analysis on existing tissue samples will not require PRC review if they do not involve more than chart review and do not require specific patient interventions. However, these studies should still be reported to the PRC for proper data and accrual tracking.

The PRC meets every second and fourth Thursday and the deadline for submissions is 5:00pm Friday 12 days before the PRC Meeting. To see the specific 2008 Schedule and Meeting Deadlines, click here.

There are four types of submissions reviewed by the PRC: Letters of Intent (LOI), NEW submissions and annual RENEWALS. Please view the appropriate links below for information about the forms required for each type of submission.

Studies are also classified as Lineberger Investigator Initiated Studies (LCCC) or Non-Lineberger Studies, i.e. Pharmaceutical, Cooperative Group, Diagnostic and Other Institutional Studies.

*UPDATED* Studies will no longer require a presubmission on an LOI prior to protocol submission. LOI's will still be reviewed administratively, but will function as a tool to provide scientific input, guidance, and other input from the PRC for those who are unfamiliar with the protocol process, or would like additional assistance at the outset of the protocol. See the Letters of Intent link below for further information.

In addition, please note the new "Amendment" section below. For more information please see the hyperlinked page for instructions for submission and what constitutes reviewable Amendments.

Studies are classified as those requesting Clinical Protocol Office (CPO) support and those which are not (Non-CPO).

I. LETTERS OF INTENT *UPDATED*

II. NEW STUDIES

III. RENEWALS- open to accrual and closed to accrual but with patients still under active treatment/intervention

IV.CLOSED TO ACCRUAL (active intervention with patients completed) - For record keeping purposes only, please send the PRC one copy of all closed to accrual (CTA) reports.We will include this information in our meetings, for notification purposes only.

V. COMPLETED- For record keeping purposes only, please send the PRC one copy of all completion notices. We will include this information in our meetings, for notification purposes only.

VI.AMENDMENTS THAT AFFECT THE SCIENCE OF A STUDY *UPDATED* - Amendment affecting the science of a study. Please see hyperlinked page for more information.

Please address all submissions to: Micah Sam, Protocol Review Committee Coordinator Lineberger Cancer Center, 3rd Floor CB #7295 Telephone: 919-843-6901 Email: msam@med.unc.edu