Qualifying Conditions and FAQs

I. Amendments Subject to PRC Review

For UNC Lineberger Investigator Initiated studies:

  • Adding a new drug to patient treatment or adding another treatment/treatment arm (e.g., radiation, surgery, etc.).
  • Changing the primary objective of the study.
  • Adding or subtracting an element from the study that changes the statistics. Please include statistician signoff with amendment review application.

Please note:  If your 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

Pharmaceutical or Other Institution studies:

  • Adding a new drug to patient treatment or adding another treatment/treatment arm (e.g., radiation, surgery, etc.).
  • Changing the primary objective of the study.

II. FAQs

1. To which studies do the amendments apply?
Amendment regulations apply to UNC Lineberger IIT and Pharmaceutical studies, but not Cooperative Group studies. Both CPO and Non-CPO studies are included.

2. What is the effective date for this process?
Amendment review procedures are effective October 1, 2007.

3.What is the procedure for submitting amendments?
Non-CPO staff should send submissions to the PRC Coordinator directly via email.

CPO staff should submit the amendment through ePRMS as a Change Review.

For both Non-CPO and CPO studies, please include a clean version and track changes version of the protocol. For UNC Lineberger IITs, please ensure that an Amendment Cover Sheet Template is attached to the front of the protocol delineating all changes being made to the protocol.  Additionally, for amendments which affect the statistics of any UNC Lineberger IIT study, please include a new biostatistician signoff form indicating review and approval of the statistics by the statistician of record for the study.

4. What would be the PRC action and how will we receive comments?
Amendments will be reviewed by the PRC Chair to determine if the amendment qualifies for an Expedited review or will be submitted for a Full Board review. A determination letter will then be issued after review.

Studies for which only statistics have been affected will receive review by a PRC statistician. If the statistician determines the amendment needs a Full Board review, the study will be placed on the next available PRC agenda.

5. What is the rationale for requiring amendment reviews by PRC? How long will amendment reviews take?
Amendments which involve a substantive change to the science or safety of the protocol will be reviewed to ensure the continued safety and efficacy of studies conducted at UNC. For studies that qualify for an Expedited review, the estimated response time is no more than two weeks from time of receipt, with most responses received in less than one business week. If a study requires a Full Board PRC review, it will be placed on the next available PRC agenda and a determination letter will be sent one to two business days following the meeting.

Please address all submissions to:

Stacy Maxwell
Protocol Review Committee Coordinator
UNC Lineberger Comprehensive Cancer Center
3rd Floor CB #7295
Telephone: 919-962-8566
Email