Amendments

Qualifying Conditions and FAQs

 

I. Amendments Subject to PRC Review

LCCC Investigator Initiated studies:

  • Adding a new drug to patient treatment or adding another treatment (ex. 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, NCI, or Other Institution studies:

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

II. FAQs

1.  To which studies do the amendments apply?

Amendment regulations will apply to LCCC and Pharmaceutical studies but not Cooperative Group.  Both CPO and Non-CPO studies are included.

2.  What is the effective date for this process?


Amendment review procedures are effective October 1st, 2007.

3.  What is the procedure for submitting amendments?

Submissions should be made to the PRC Coordinator directly via email An icon indicating that a link will launch an email program..  Please include the Amendment with cover sheet delineating all changes to protocol and any new or revised consent forms reflecting the changes to the study.

For amendments which affect the statistics of the study, please include a new biostatistician signoff An icon indicating that a link will open a Microsoft Word document. 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 administratively by the PRC Chair (except studies for which the PRC Chair is involved to be reviewed by the Co-Chair).  If an amendment is approved then a letter will be issued to that effect by the PRC Coordinator.  If the study requires further review (as determined by the PRC Chair) it will receive a full PRC review and be placed on the next available PRC agenda.

Studies for which only statistics have been affected will receive review by a PRC statistician.  If determined to need full review by the statistician, 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 review 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.  As stated above, amendments requiring review will receive an administrative review by the PRC Chair, Co-Chair or statistician.  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 full PRC review, it will be placed on the next available PRC agenda and receive a response one to two business days following the meeting.

Please address all submissions to:

Micah Sam
Protocol Review Committee Coordinator
UNC Lineberger Comprehensive Cancer Center
3rd Floor CB #7295
Telephone: 919-843-6901
Email An icon indicating that a link will launch an email program.