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, christinegrace_narag@med.unc.edu.
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 for CTO Managed Trials
- PRC Amendment Cover Sheet for Non-CTO Managed Trials
- 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. 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