For any clinical trial, the following requirements have become mandatory from a data and documentation standpoint:
- Set up processes and procedures in line with the International Conference of Harmonization (ICH) Good Clinical Practice (GCP) guidelines
- Transparency, data visibility, and seamless flow of information across the trial lifecycle
- Steps to ensure the validity and integrity of trial data
To facilitate the evaluation of the conduct of a clinical trial, CROs need to put together an Electronic Trial Master File (eTMF) that accurately captures the activities that will be performed during the course of the trial and the key decisions taken related to the trial.
This is also required by the EU Commission Directive 2005/28/EC 63 Chapter 4 Article 16 and FDA’s CFR 21 Part 11.
These documents also need to be audit-ready and easily accessible for an inspection by regulatory authorities. Inability to provide comprehensive TMF has often been identified as a major problem during clinical trials.
Looking for a modern eTMF to collaborate better and be prepared for an FDA inspection anytime? At ComplianceQuest, we offer a modern, cloud-based eTMF solution. Request for a demo here: https://www.compliancequest.com/online-demo
In this blog, we highlight why ComplianceQuest’s eTMF is an ideal solution for CROs and sponsors.
Compliance: Due to the number of documents involved, manual management of the TMF can be very time-consuming and prone to errors. By digitalizing the process, CROs and sponsors can benefit from real-time visibility into all eTMF artifact activities and integrate with other quality and compliance-critical functions.
The CQ eTMF solution provides a view of what is required, what is completed, and what is missing in the eTMF at all times. The application of the DIA TMF Reference Model helps automate the entire lifecycle of eTMF and alleviates administrative burden through features such as:
- Pre-built templates
- ZIP file downloads to facilitate file submissions
- Folder structure access on clinical study record level
- Restricted/user permission configured file access
- Drag & drop files
- Bulk import/export artifacts and related documents
This helps improve compliance as well as provides improved visibility into trial compliance gaps that can be converted into corrective and preventative actions.
Reports and Dashboard: Reports and dashboards provide stakeholders with insights into critical metrics such as timeliness, quality, missing approvals, expiring documents, and completeness of eTMF. The study team and management can assess the health of all clinical documents and the gaps identified to align site/study management for improved compliance.
Collaboration: One of the greatest advantages of the CQ eTMF solution is that it facilitates collaboration, exchange, and tracking of information from within a single system. By providing secure and direct access to the documents, it enables instant viewing and sharing of data, records, and documents by the clinical study team.
It also makes it easy to assign, create, collaborate, review, and approve all TMF artifacts with better efficiency. Users are alerted when a particular item needs their attention. The Chatter function allows study teams to brainstorm changes to artifacts in real-time and have access to everything that was discussed.
Organized Storage: Unlike in a file server, the eTMF covers end-to-end strategies, methods, and tools used through the lifecycle, and is organized such that core documents are collated together and site-related documents are bundled into a section. With appropriate naming and access control, retrieving documents with proper authentication becomes easy.
Easy Searchability: CQ eTMF solution supports full-text search of documents, metadata, and attachments to find and review critical trial information faster. Study teams can spend less time searching and more time managing the eTMF process. In addition, you can easily generate reports from any data collected in the system.
Ensures Business Continuity: Being a cloud-based solution, the CQ eTMF can be accessed from anywhere, anytime, and on any device, ensuring business continuity and clinical efficiency, visibility, and flexibility.
Improved Trial Visibility: By providing a unified view of all trial-related data, records, and documents, the CQ eTMF solution improves visibility and flexibility. This can help prevent potential major non-compliance events through on-time adverse event reporting and timely interventions.
Integrated with a next-generation EQMS: Over and above these benefits is the fact that CQ eTMF is integrated with ComplianceQuest’s EQMS solution. This plays a key role in integrating quality-related processes into the clinical workflow. For instance, if you find an issue in the eTMF, it is not easy to trigger a CAPA and plan next steps to fix the problem at hand.
To know more about the CQ eTMF solution and how it can improve eTMF document management efficiency, quality, and risk management