In this short edition of What's New in E6 R3, we look at the Sponsor Responsibilities section on Non-Compliance.
The three points from R2 are reproduced in R3 with one significant addition and a few minor wording changes.
- Sponsors should react promptly to secure compliance for non-compliance by clinical site staff or the "sponsor's staff." Notably, this step has not been updated to include non-compliance by service providers.
- If non-compliance significantly or potentially significantly affects "trial participant's rights, safety or well-being" (changed from "human subject protection" or reliability of results, sponsors are still required to perform a root cause analysis and implement appropriate corrective and preventive actions. R3 adds a requirement for sponsors to confirm that CAPAs were adequate "unless otherwise justified." This step also includes a new requirements for sponsors to notify regulatory authorities and/or Institutional Review Boards/Independent Ethics Committees (IRBs/IECs) of significant issues per requirements.
- Sponsors are still required to terminate persistently non-compliant sites, notifying regulatory authorities, and this step also now adds a requirement to notify the IRB/IEC as appropriate.
