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The QMN Weekly Bulletin

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

April 21, 2017

The European Medicines Agency says clinical trial master files should also include quality reports and checklists, product certifications and trial-specific computer system guides — essential documents that are not listed as required in ICH Good Clinical Practice guidelines.

An EMA draft guideline says any documentation that would help evaluate the trial’s conduct should be included in the file, whether they were explicitly listed in guidelines or not.

Regardless of paper or electronic formats, trial master file information should be verifiable with an audit trail and should protect subject confidentiality, according to the guideline on complying with EU clinical trial regulations.

In organizing the master file, it is essential to segregate documents held by the sponsor and those held by the investigator, while avoiding duplication—for example, separating product-development level documents such as training records, SOPs or product brochures, as well as relevant GMP information.

Per the EU regulation, clinical master files need to 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 two years after the last approval. Subject medical files should be retained in accordance with national regulations, the guideline says.

The new FDAnews management report Risk-Based Monitoring of Clinical Trials 2017: New Trends and Best Practices will show you, step-by-step, how to properly design and implement your risk-based clinical trial monitoring program to fully satisfy the FDA’s requirements.

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