Oncology Protocol Review Committee

NEW STUDIES

The PRC reviews oncology studies from UNC investigators, including clinicians and research scientists, as well as cooperative groups, pharmaceutical companies and other institutions. Some of these studies will require the use of the Clinical Protocol Office (CPO), while some trials will use other resources. If you are requesting Clinical Protocol Office services, please see Section 1, below. If you DO NOT need CPO Office services, see Section 2 below. If you are not sure what you need, please contact the PRC Coordinator (843-6901) for guidance.

SECTION 1. REQUESTING CLINICAL PROTOCOL OFFICE SERVICES:

The Clinical Protocol Office (CPO) supports the design and conduct of oncology clinical trials. To request CPO services, you must submit the items below to the PRC Coordinator.

**UPDATE** Please note, any protocol that is investigator initiated from an outside institution (such as a protocol originating from Dana Farber, MGH, USC, etc.) must include a cover page/header indicating that the submitted document is the FINAL VERSION and either feature a version number or version date. All protocols without this information clearly indicated will not receive PRC review. **UPDATE**

1. PRC Submission Cover Sheet

(a) This form indicates which CPO Services are requested for the study being submitted and acts as a face page for efficient routing through the PRC.

(b) The PRC submission cover sheet must include the Disease Group Leader sign-off, estimated UNC patient numbers and prioritization, list of PIs and Co-PIs, and if the study will require GCRC support. If the Disease Group Leader for a study is out of town, the Disease Group Co-leader's signature is sufficient. The Phase I Disease Group Leader (Claire Dees, MD) must sign off on all non disease specific Phase I studies:

GI/GU	O’Neil, leader Pruthi, co-leader		PhaseI/Melanoma/Orphan	Dees, leader Ollila, co-leader
Breast Cancer	Carey, leader DeMore, co-leader		Hematologic Malignancies	Shea, leader Morris, co-leader
Lung/Head and Neck	Socinski, leader Couch, co-leader

2. Final Protocol

(a) If your study is a UNC Investigator Initiated study, you must submit your protocol using a Lineberger Protocol Template NEW!

(b) If your study is a correlative science study (any study involving sample collection with or without supporting data), you must use the Correlative Science Template

(c) Hard copies will no longer be accepted for PRC Submissions excepting extenuating circumstances. Please submit electronic copies to the the PRC Coordinator. For further information about this new policy please see the page here. NEW!

3. Biostatistician Sign-Off Sheet - (If Investigator Initiated, Lineberger Study)

4. Investigator's Brochure

(a) An Investigator's Brochure is required for all non FDA approved drugs for Phase I, II and III Studies. A PRC reviewer may request an Investigator's Brochure for an approved drug if he or she finds it to be necessary to adequately review a study. The PRC Coordinator will inform PIs and or Study Coordinators if an IB has been requested by the PRC reviewer.

If you have not requested PRC/IRB package preparation as one of the Clinical Protocol Office Services, please proceed with the new study requirements detailed in section 2. If you have any questions about your study submission, please call the Clincal Protocol Office at 966-4432.

SECTION 2. NOT REQUESTING CLINICAL PROTOCOL OFFICE SERVICES:

The following items are needed for a new study submission:

**UPDATE** Please note, any protocol that is investigator initiated from an outside institution (such as a protocol originating from Dana Farber, MGH, USC, etc.) must include a cover page/header indicating that the submitted document is the FINAL VERSION and either feature a version number or version date. All protocols without this information clearly indicated will not receive PRC review. **UPDATE**

1. PRC Submission Cover Sheet - This must include estimated UNC patient numbers and prioritization, list of PIs and Co-Is, and if the study will require GCRC support.

2. Clinical Protocol*

(a) If your study is a UNC Investigator Initiated study, you must submit your protocol using a Lineberger Protocol Template NEW!

(b) If your study is a correlative science study (any study involving sample collection with or without supporting data), you must use the Correlative Science Template

3. Investigator's Brochure

(a) An Investigator's Brochure is required for all non FDA approved drugs for Phase I, II and III Studies. A PRC reviewer may request an Investigator's Brochure for an approved drug if he or she finds it to be necessary to adequately review a study. The PRC Coordinator will inform PIs and or Study Coordinators if an IB has been requested by the PRC reviewer.

4. IRB Application - For the IRB application, see the IRB forms webpage.

5. Informed Consent and HIPAA consent forms - These and other forms can be found on the IRB Submissions webpage.

6. Any Recruitment Materials or Quality of Life Surveys

7. Biostatistician Sign-Off Sheet - (If Investigator Initiated, Lineberger Study)

Please submit ONE copy of all of these materials to the PRC Coordinator electronically.

* DO NOT SUBMIT ORIGINAL VERSIONS OF YOUR PROTOCOL. IF YOU ARE NOT REQUESTING CLINICAL PROTOCOL OFFICE PREPARATION SERVICES WE WILL NOT FORWARD ON YOUR PROTOCOL AND ALL FORMS WILL BE RECYCLED SECURELY AFTER PROTOCOL REVIEW *

Once you receive an approval letter from the PRC, you can then submit this letter with the entire package (and the appropriate number of copies) to the IRB. The PRC does not forward approved studies to the IRB, that is the responsibility of the PI (or the Regulatory Department of the Protocol Office, if applicable).