Using eTMF in Clinical Trials to Accelerate Approvals
There are many aspects of clinical trials, mostly documents, including protocols, informed consent documents, safety reports, monitoring data, audit trails, and investigator site files. Altogether, they comprise the TMF, or Trial Master File. Transitioning from paper to an electronic format, an electronic Trial Master File (eTMF) can improve operations, compliance, and regulatory approval timeframes.
What is an eTMF and Why is it Important?
An eTMF is the electronic version of the TMF. It provides real-time access, electronic storage, complete audit trails, and evidence of required documents tracked throughout the life of a clinical trial. Regulators like the FDA and EMA expect that trials document everything in full and that they be accurate and complete. eTMFs help ensure the appropriate documentation is never absent or lost.
Key Benefits:
- Inspection readiness: eTMFs keep documents organized, indexed, and updated so audits and inspections can be conducted at any time without panic.
- Reduced time for document retrieval: Teams can search for and access documents in an instant without physically locating and reviewing the paper files.
- Collaboration of stakeholders: Sponsors, CROs, investigators, and regulatory agencies can work together more efficiently when everyone has access to the same centralized document repository.
Main Features and Recommended Practices
Implementing an eTMF successfully is more than just basic file storage. Some of the important practices include:
- Tagging with metadata: Each document should be labelled with metadata (trial stage, site, document type) so that it can be organized logically, searched, and tracked for completeness.
- Automated workflows: The submission of documents, review, version control, and approval are all now tasks that can be automated to reduce human error and delay.
- Quality checks and completeness tracking: Routine audits of how many essential documents are either missing, delayed, or not complete can help address these issues quickly.
- Access controls and audit trails: Authorized access to documents and audit trails should mention the clear history of actions taken.
Expediting Approvals
More often than not, regulatory reviews and approval timelines lag due to documentation deficiencies like loss of signatures, out-of-date documents or non-indexed and inconsistent formats. A company can mitigate these delays by ensuring its eTMF is always ready for inspection.
An eTMF allows people to view the complete and historical document trail and provides context around any changes. Regulators can quickly check for compliance without having to communicate back and forth with trial sites and companies. As a result, trials are often submitted and approved quickly, and fewer regulatory findings mean trial timelines can reach the market without any delays.
The electronic trial master file is a key asset for increasing efficiency, accuracy, and compliance. An organization that employs thorough electronic trial master file systems, like those from providers like Egnyte, using strong metadata structures, automated workflows, and secure audit trails will be able to reduce the risks of delays and help keep its trials progressing smoothly as per the regulatory standards.
