EMA Offers Draft Guideline on Trial Master Files

Regulatory News

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections.

"This guideline aims to collate and explain the requirements for the TMF as covered in the Regulation [(EU) No 536/2014] and ICH-GCP E6 to assist organisations in maintaining a TMF that facilitates trial management, GCP [good clinical practice] compliance and inspection. The document also addresses archiving of the TMF, clarifying retention times, in particular expectations in case of digitization and consecutive destruction of paper documentation," EMA notes.

Sponsors and investigators are expected to keep the TMF up to date and ensure that it is complete at the end of a trial, EMA says, noting that sponsors are also recommended to conduct routine quality assurance checks of the TMF.

In terms of preparing for a TMF inspection, the guideline says inspectors should have read-only access, though organizations "should be aware that GCP inspectors may have rights to seize original trial documentation if circumstances arise that require it."

And according to Article 58 of the clinical trial regulation, the sponsor and the investigator "shall archive the content of the clinical TMF for at least 25 years after the end of the clinical trial."

Draft guideline on good -clinical -practice compliance in relation to trial master file (paper and/or electronic) for content, management, archiving, audit and inspection of clinical trials