After a lengthy consultation period and delays – mostly caused by Brexit! – the EMA has published its long-awaited guideline: “Guideline on the content, management and archiving of the clinical trial master file (paper and/or electronic)“. This replaces the previously published draft guidance and reflection papers on this topic.
Although a guidance document rather than mandatory rules, it comes into effect on 6th June 2019. However, I’m sure most will be taking efforts to ensure the guidance is adopted as soon as possible!
The guidance clarifies many of the topics that industry has been struggling with and discussing recently, including certified copies…. certified copies can be used whenever copies are used instead of originals but copies must be certified copies if they “irreversibly replace originals”. There is also guidance regarding archiving of audit trails in section 6.
The EMA have also published revised “Questions & Answers” on GCP topics, including the Trial Master File. You can read the Q&As here.
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