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 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.

The PRC meets every second and fourth Wednesday and the deadline for submissions is 5:00pm Friday, 12 days before the PRC MeetingAn icon indicating that a link will open a Microsoft Word document..

Submissions are required in Electronic Format.

There are three 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.

I. LETTERS OF INTENT

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 - Amendment affecting the science of a study.

Please address all submissions to: Micah Sam, Protocol Review Committee Coordinator Lineberger Cancer Center, 3rd Floor CB #7295 Telephone: 919-843-6901 Email Another icon indicating that a link will launch an email program.