FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

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

April 21, 2017
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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.

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