Electronic Trial Master File (eTMF)
The Trial Master File is a structured set of files used by sponsors and CROs to demonstrate proof of regulatory and ethical requirements for conducting clinical trials. It includes documentation of the following items:* Regulatory and ethical requirements for the trial* Data management plan* Quality control procedures* Clinical protocol* Statistical analysis plan* Safety reporting plan* Protocol deviations* Other relevant documentationThe Trial Master File is designed to provide an audit trail of the entire clinical trial lifecycle from start to finish.
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