Good clinical practice for clinical trials – updated December 2025

15th December 2025

Good clinical practice for clinical trials – updated December 2025

Summary:
The guidance — part of the Good clinical practice: guidance and inspections collection — was last updated on 12 December 2025 to reflect current MHRA practice on how sponsors, investigators and trial sites should meet internationally recognised GCP standards and what to expect during a GCP inspection. 

Key additions and refinements include updated pre-inspection documentation expectations and tools, such as a GCP inspection dossier template and checklist, which help trial teams assemble essential documentation in advance of an inspection. These practical resources strengthen readiness and support systematic organisation of key records relating to trial conduct, participant safety, consent, protocol adherence, investigational product oversight and data integrity.

The refreshed guidance continues to emphasise MHRA’s risk-based inspection approach, where inspections may be routine, triggered by serious breaches, or occur in the context of marketing-authorisation applications. Sponsors are reminded to maintain continuous inspection readiness, with structured documentation and clear evidence of compliance with core GCP principles. The December update also aligns the guidance with broader regulatory reform underway — including the phased introduction of updated clinical trials legislation and evolving international GCP expectations (ICH E6 (R3)), which the MHRA plans to incorporate into future guidance as the UK transition to new rules approaches. 

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

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