Reflection paper on laboratory processes for clinical trials

The Reflection paper for laboratories that perform the analysis or evaluation of clinical trial samples (EMA/INS/GCP/532137/2010) was adopted by the Good Clinical Practice Inspectors Working Group on 28 February 2012. It was developed to address the lack of comprehensive regulatory guidance for laboratories analysing clinical trial samples and to support quality systems that protect trial subjects and ensure data are reliable, traceable and accurately reported.

It applies to contract research organisations, sponsor laboratories and non‑commercial, hospital or academic laboratories that generate safety, efficacy, pharmacokinetic or other endpoint data for clinical trial dossiers, including investigator‑initiated trials. It does not apply to non‑interventional trials. The legal basis links the paper to Directive 2001/20/EC, Directive 2005/28/EC and the International Council for Harmonisation good clinical practice guideline.

The document is organised into 22 subsections covering the full laboratory process:

• Organisation and personnel: roles, responsibilities, qualifications, training records and good clinical practice training.
• Contracts and agreements: service agreements, trial‑specific contracts and subcontracting arrangements.
• Trial conduct: protocols, work instructions, deviations and communication pathways.
• Requests for additional work and sub‑contracting.
• Patient safety and informed consent: reporting of critical or anomalous results and management of consent withdrawal.
• Sample labelling, receipt, storage and chain of custody: transport, temperature monitoring, sample integrity and subject confidentiality.
• Method validation and repeat analysis: validation requirements, acceptance criteria and rules for repeat testing.
• Data recording and reporting: data integrity, audit trails and complete reporting of results.
• Facilities, equipment maintenance and computerised systems: fitness for purpose, qualification, calibration, validation and disaster recovery.
• Quality assurance and quality control: audits, corrective and preventive actions, peer review and internal controls.
• Standard operating procedures, blinding and unblinding, data retention and archiving, and preparation and distribution of clinical kits.

This reflection paper is a practical benchmark for assessing whether hospital, academic and other trial laboratories have appropriate organisation, documentation, validation, data management, quality assurance and archiving in place to withstand good clinical practice inspection. A practical starting point is to review the scope and legal basis to confirm relevance, then use section 6 as a checklist when drafting or reviewing laboratory contracts, standard operating procedures and quality system documents.