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Amendments

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.

II. Procedure

Required documents include:

  • Clean version of protocol amendment
  • Track changes version of protocol amendment
  • Summary of Changes of protocol amendment (if available)
  • PRC amendment cover sheet
  • Statistician signoff (if study is a UNC Lineberger IIT and amendment has significantly changed the statistical section

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.

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.

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