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I. Amendments Subject to PRC Review

For UNC Lineberger Investigator Initiated Studies (IITs):

  • Significantly changing the study design, such as adding a new disease group, adding a new drug to patient treatment, adding a new cohort or substudy, or adding another treatment modality (e.g., radiation, surgery, etc.).
  • Changing the primary objective or primary endpoint of the study.
  • Significantly changing the statistical section, such as an increase or decrease of ≥10 percent in accrual goal, or adding or subtracting an element from the study that changes the statistics. Please include a statistician signoff with the amendment review application.
  • Adding a collection of new or additional biomarker samples.

For Pharmaceutical or Other Institution Studies:

  • Significantly changing the study design, such as adding a new disease group, adding a new drug to patient treatment, adding a new cohort or substudy, or adding another treatment modality (e.g., radiation, surgery, etc.).
  • Changing the primary objective or primary endpoint of the study.

Cooperative Group studies do not need to submit amendments for PRC review.

Please note that the UNC IRB may require a PRC approval letter for qualifying amendments. If you have any questions about whether or not your amendment needs to be reviewed, please contact the PRC Coordinator, christinegrace_narag@med.unc.edu.

II. Procedure

Required documents include:

UNC Lineberger IITs should have a Summary of Changes attached at the beginning of the protocol delineating all changes being made to the protocol.

CTO staff should submit the amendment through ePRMS as a Change Review. Refer to this resource for more information on how to retrieve the Oncore coversheet data report: How to Retrieve the Oncore Coversheet Data Report

Non-CTO Staff who have received OnCore/ePRMS training should also submit the amendment through ePRMS. Non-CTO staff who have not yet received OnCore/ePRMS training should send submissions to the PRC Coordinator directly via email – contact the PRC Coordinator, christinegrace_narag@med.unc.edu.

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:

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