EMA Publishes Draft Guideline on Complying with Clinical Trial Master File Requirements

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Is adhering to ICH Good Clinical Practice guidelines enough to ensure compliance?

The European Medicines Agency’s latest guideline says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides. These essential documents are not listed as required in ICH Good Clinical Practice guidelines. This guideline includes the following:

• Documentation that would help evaluate the trial’s conduct should be included in the file, whether they were explicitly listed in guidelines or not.

• Both paper and electronic TMF information should be verifiable with an audit trail and should protect subject confidentiality.

• TMF organization should segregate documents held by the sponsor and those held by the investigator, while avoiding duplication (i.e., separating product-development level documents such as training records, SOPs or product brochures, as well as relevant GMP information).

• Clinical master files must be archived for at least 25 years following the end of the clinical trial. For all trials that support a marketing authorization, essential documents must be retained for at least 15 years, or at least 2 years after the last approval. Subject medical files should be retained in accordance with national regulations.

Download the guidance here.