A Traditional Paper Master File (TMF) is a physical collection of documents that are used to store and manage important information related to a clinical trial. These documents are typically stored in binders or folders and are usually kept in a secure location, such as a study site or sponsor’s office.
An Electronic Master File (eTMF) is a digital system used to store, manage, and track the progress of important trial-related documents, such as informed consent forms, study protocols, investigator brochures, and regulatory submissions. The eTMF system is designed to replace traditional paper-based systems and improve the efficiency, security, and accessibility of trial-related documents.
The main differences between paper TMF and eTMF are as follows:
- Accessibility: eTMF allows for easy access to documents from any location and at any time, while paper TMF requires physical access to the documents.
- Collaboration: eTMF allows for easy sharing and collaboration among different members of the trial team, while paper TMF can be difficult to share and collaborate on.
- Security: eTMF typically includes multiple layers of security, such as user authentication and access controls, while paper TMF is vulnerable to unauthorized access and tampering.
- Tracking and monitoring: eTMF allows for easy tracking and monitoring of the progress of the trial, while paper TMF can be difficult to track and monitor.
- Compliance: eTMF is compliant with FDA regulations and is 21 CFR Part 11 compliant, while paper TMF is not compliant with any regulations.
- Cost: eTMF systems can be costly to implement and maintain, while paper TMF is relatively low-cost.
In summary, eTMF is a digital system that improves the efficiency, security, and accessibility of trial-related documents. It allows for easy sharing and collaboration, tracking, and monitoring of the progress of the trial, and is compliant with regulatory requirements. On the other hand, paper TMF is a physical collection of documents that is relatively low-cost but can be difficult to share, collaborate on, track, and monitor. Paper TMF can be inefficient, limit accessibility and collaboration, and increase the risk of damage or loss, which makes it difficult to ensure compliance with regulations.