Clinical trial records in hospital pharmacy

Using our advice

Hospital pharmacy teams create and maintain a wide range of records to support the management of clinical trials. These records demonstrate compliance with ICH Good Clinical Practice (GCP), support participant safety, ensure investigational medicinal product (IMP) accountability and provide evidence for regulatory inspection.

Clinical trial records have retention periods that are longer than routine healthcare records.

Supporting source

The retention requirements in this article are based primarily on ICH E6(R3) Good Clinical Practice and UK Clinical Trial Regulations. Pharmacy organisations should also consider sponsor-specific requirements where these may exceed the minimum retention period.

Where multiple retention periods apply, organisations should normally retain records for the longest applicable period. See Retaining and storing pharmacy records in England (SPS page) for factors that may justify longer retention.

Trial Master File (TMF)

Most pharmacy clinical trial records will be held as part of the Trial Master File (TMF) which has a minimum retention time of at least 25 years after the end of the trial.

If at 25 years, the trial data is being used to support a UK marketing authorisation license, the essential documents are retained for at least another 2 years once market authorisation has been granted.

Essential documents

Retain records for at least 25 years after the end of the trial where they form part of the essential trial documentation required under UK Clinical Trial Regulations and ICH Good Clinical Practice.

Essential trial documentation is defined as documents that:

• enable both the conduct of the clinical trial and the quality of the data produced to be evaluated
• show whether the trial is, or has been, conducted in accordance with the relevant requirements of the UK Clinical Trial Regulations

Section C.3.3 of ICH Good Clinical Practice has a table listing essential trial documentation. It broadly includes:

• agreements, contracts and insurance
• authorisation and governance
• data integrity
• participant information including healthy people
• randomising and blinding
• safety reporting
• supply

ATiMPs

• retain Advanced Therapy Investigational Medicinal Product (ATiMP) records for at least 30 years after product expiry

Supporting source

The MHRA Archiving and retention of clinical trial records advises retention for traceability.

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