Instructions for Submitting Clinical Trial Materials

The Protocol Review Committee (PRC) is a multidisciplinary standing Committee of the UNC Lineberger Comprehensive Cancer Center  and the UNC Clinical Cancer Program; a joint entity of UNC Lineberger, 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). The PRC’s primary function is to ensure the scientific quality and patient safety of proposed studies. The PRC also monitors study accrual and recommends closure of under-performing trials (via annual renewal review).

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

UPDATES TO PROCEDURE

The PRC has recently updated the procedure for submissions by instituting limits on the number of reviews per meeting – five initial studies and/or amendments, and ten renewals, with potential excess Closed to Accrual renewals to be addressed as indicated below.

This has been the PRC’s system for some time, but it was decided to codify the process in order to help everyone plan their submissions accordingly.

This change will take place starting with the PRC meeting on March 7, 2018.

  • PRC agendas will be capped at five initial reviews (either new studies or, when necessary, amendment reviews).
    • Initial studies will be accepted in chronological order of submission, with any studies submitted after the cap is reached deferred to the following agenda.
    • Initial studies requested for review on an agenda that has already met its limit will be required to outline all extenuating circumstances in a written rationale to be considered by the PRC Chair or Co-Chair.
  •  Total renewal reviews per agenda will be capped at 10 total.
    • Any Open to Accrual renewals submitted after the cap is reached will be deferred to the following PRC Agenda for review.
    • All Closed to Accrual renewals that cause the 10-limit renewal cap to be exceeded will be assigned to a rotating list of PRC Reviewers.
      • Any concerns generated by the Administrative review of these renewals will be communicated to the PRC Chair or Co-Chair, who will present the renewal to full PRC board for discussion.
      • If no issues are identified, these studies will be noted on the PRC agenda for notification purposes only, with the understanding that they are approved without condition.

For PRC Meeting dates and deadlines for submission, please see the PRC Calendar

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

I. LETTERS OF INTENT - Please note: Studies will no longer require a presubmission on an LOI prior to protocol submission. LOI's will be reviewed at a full PRC Meeting (with a single Member providing a review), and 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.

II. NEW STUDIES

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

A. 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.

B. 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.

IV. AMENDMENTS THAT AFFECT THE SCIENCE OF A STUDY - Amendment affecting the science of a study. PLEASE NOTE:

 If this study is run under an IND, submission of this amendment to the FDA may be required, per 21CFR312.30 (b).   Please review the following criteria and submit accordingly:

 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.30

Please address all questions regarding the above to the .