The European Medicines Agency (EMA) has updated a set of 15-year-old annexes about the procedures for conducting good clinical practice (GCP) inspections requested by the Committee for Medicinal Products for Human Use (CHMP).
EMA published the five annexes in 2007. Since then, the regulatory landscape has changed, most notably through the adoption and recent implementation of the Clinical Trial Regulation (CTR). Many of the new additions to the annexes relate to CTR, which has provided the basis for the use of a risk-proportionate approach to clinical trial design and conduct that inspectors should consider when reviewing studies.
The five annexes cover the procedures related to investigator sites, clinical laboratories, sponsors and contract research organizations (CROs), record keeping and archiving of documents and bioanalytical part, pharmacokinetic and statistical analyses of bioequivalence trials. EMA is yet to update two other texts in the series that cover computer systems and Phase 1 units.
EMA has retained the structure and much of the content of the older documents while making extensive changes to the details. In the annex focused on sponsors and CROs, the agency has added a subsection on noncompliance, explaining that inspectors should assess the procedures for reviewing and submitting “potential and actual serious breaches, including log, confirmations for decisions, outcomes and CAPAs.”
The agency has also updated existing subsections with new priorities for inspectors. EMA now wants inspectors to evaluate systems for standard operating procedures and associated documents, and to determine if the sponsor or CRO’s procedures include a description of a risk-proportionate approach to monitoring and the rationale for the chosen monitoring strategy in trial-specific monitoring plans.
EMA has made similar changes to the annexes focused on other organizations. The updated annex on investigator sites calls on inspectors to determine if informed consent was obtained in compliance with CTR “by examining an appropriate sample of trial participants (including the trial participants whose medical records are reviewed), or the trial participants’ legally acceptable representative, prior to their entry into the study.” The review should now include “documentation in the source data of the process of obtaining the initial informed consent and subsequent consent to updates, including pediatric assent and emergency consent.”
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