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I. Amendments Subject to PRC Review

For UNC Lineberger Investigator Initiated 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.
  • 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. If you would like to discuss whether or not your changes meet this qualification, please contact the PRC.
  • 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 an Amendment Cover Page attached to the front of the protocol delineating all changes being made to the protocol.

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

Non-CPO staff will send submissions to the PRC Coordinator directly via email – contact the PRC Coordinator.

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