Other CCR Audits

The CCR Office of Education and Compliance conducts other audits throughout the year as needed to ensure that research is being conducted as required by regulations, policies and the research protocol. 

For example, protocol 01C0129 is used throughout the CCR to screen for subsequent treatment protocols; and protocol 04C0165 is used throughout the CCR to provide medical consultation, provide standard of care treatment or follow-up of disease; screen donors of cellular products , and genetic follow-up.  These protocols are audited to ensure that there is documentation that the protocol is being used appropriately.

Protocol 01C0129 Appropriate Use

2023:  Overall Audit Summary
2022:  Overall Audit Summary

Protocol 04C0165 Appropriate Use

2024:  Overall Audit Summary
2023:  Overall Audit Summary
2022:  Overall Audit Summary

Embedded Agreement Information in PRES
as of October 2023, PRES embedded agreements are reviewed during the IC process

2023:  Audit of CCR, CTEP and Industry-Sponsored Studies 
2022:  Audit of Industry-Sponsored Studies