Updates to Good clinical practice for clinical trials guidance – new CAPA guidance

2nd March 2026

Summary: On 27 February 2026, this guidance was updated to attach new CAPA guidance intended to help organisations formulate appropriate responses following Good Clinical Practice (GCP) inspections. The new attachment provides a CAPA plan template that sponsors and trial sites should use to address inspection findings and demonstrate how they will correct issues and prevent recurrence. The guidance notes that, for some inspections, companies may also be asked to provide periodic reports on progress against the proposed CAPA actions. This update is designed to improve clarity around expectations for corrective and preventive actions after a GCP inspection and support better inspection outcomes.

Link: https://www.gov.uk/guidance/good-clinical-practice-for-clinical-trials

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