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Audit Changes from ICH GCP R2 to R3
For sponsors, CROs, auditors, and quality teams, how audits are designed and executed today will shape the future of clinical trial oversight.
The upcoming implementation of ICH GCP R3 introduces changes that auditors and quality assurance teams must carefully consider. To support clear understanding and effective implementation, the following table summarizes key updates from ICH GCP R2 to R3 regarding audit requirements:
Practical Implications for Auditors:
  1. Study-Specific Criteria: If a study starts (or continues) under the new ICH GCP R3 rules, audit planning and the classification of findings may need to follow the revised sections in R3.
  2. Transition Period: Sponsors must determine whether a study initiated under R2 standards should shift to R3 requirements mid-study. This can affect how audit findings are categorized and addressed.
  3. Tool Updates: Any instruments or templates used by auditors (e.g., checklists or classification spreadsheets) should be updated to map to the new sections and guidance points in R3. This ensures consistency in how findings are reported and managed.
  4. Audit Planning: Given the risk-based emphasis, sponsors may need to adjust their audit schedules and approaches, focusing more closely on high-risk areas identified under R3.
  5. Training Requirements: Auditors and QA teams require comprehensive retraining to apply ICH GCP R3 standards correctly. This includes clarity on which sections have changed, how new definitions apply, and how to handle ongoing or hybrid R2/R3 trials.


Next Steps:
  • Procedures Update: Internal SOPs should incorporate clarifications around auditing frequency, scope, and regulatory certificate requirements under R3.
  • Enhanced Tools: Specialized software or spreadsheets can standardize classification and documentation of audit findings, reflecting the new R3 framework.
  • Continued Education: Timely training programs will help auditors and QA personnel stay up to date on the latest requirements, ensuring consistent compliance.
The QARP Support for ICH GCP R3 Implementation

The QARP offers comprehensive assistance to help sponsors and auditors transition smoothly to ICH GCP R3:
  1. Excel Tool (R2→R3 Comparison): A convenient spreadsheet highlighting what changed from R2 to R3. Order the R3 training before 31 March 2025 and receive this tool free.
  2. R3 Training: Dive deeper into the specifics of the revised guideline and gain hands-on practice at https://theqarp.com/e6r3. We have special training for experts including auditors.
  3. Audit Planning & Execution: We support Sponsors, service providers and medical organizations with planning and conducting audits according to R3 requirements, ensuring a risk-based approach.
  4. R2 vs. R3 Gap Analysis: Our experts will evaluate your current processes, pinpoint gaps, and provide a tailored roadmap to achieve R3 compliance.

If you have any questions or need assistance in implementing these changes, please reach out!