In the pharmaceutical and medical device industries, maintaining a Trial Master File (TMF) that is complete, accurate, and compliant is critical for successful clinical trials. However, the process of achieving this goal can be time-consuming and costly, particularly when dealing with paper-based documents. In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an electronic TMF (eTMF) system. By following these guidelines, sponsors and CROs can significantly reduce the burden of paper-based document management and streamline their clinical trial processes.
Going Paperless: Best Practices for Creating Certified Copies
In this white paper, we explore the regulatory requirements, processes, and best practices related to creating certified copies of original documents within an eTMF system.