Q&A 19 : Does the Quality Risk Management Plan needs to be included in the CSR?

“I may have misunderstood, but did you say that the Quality Risk Management Plan needs to be included in the CSR?”

IGH GCP Ref: 5.0.7

ICH E6 R2 5.0.7 Risk Reporting: The sponsor should describe the quality management approach implemented in the trial and summarize important deviations from the predefined quality tolerance limits and remedial actions taken in the clinical study report (ICH E3, Section 9.6 Data Quality Assurance).

Our recommendation is that the QRMP is included as an addendum or summarized in section 9.6 to meet the first requirements and the second requirement of deviations from QTLs are also summarized together with actions taken and any changes made to the QRMP as a result of the deviations.

  Tammy Finnegan, COO  tammy.finnigan@tritrials.com

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