Episode Notes
Resources:
[email protected]: Use this email to let us know what you want to hear about.
Let’s extend a warm welcome to Amélie Rivet, Associate Director of eTMF Operations at Innovaderm. Amélie is a seasoned clinical project manager with extensive experience in managing global trials across North America, Europe, and Asia within the CRO environment. She has a deep understanding of all the clinical steps leading to the success of a clinical trial, from start-up to closeout. Well versed in regulatory requirements and adept at managing multidisciplinary teams, Amélie will share her insights on the main takeaways from the CDISC TMF US Interchange conference which took place in Arizona last October.
The conference was absolutely fantastic. For those unfamiliar, this yearly event gathers trial master file (TMF) experts from various organizations. Sponsors, CROs, TMF consultants, vendors, and auditors were all present, providing a comprehensive experience. Whether well versed in TMF requirements or just starting in the field, the conference offered presentations and panel discussions for all levels. This year included a special session with a Food and Drug Administration (FDA) inspector. The event provided excellent opportunities for networking and meeting with TMF vendors. Attendance is highly recommended for anyone interested in TMF, especially those looking to implement it in their organization.
Most Trending Topics
At the conference, the Reference Model Steering Committee generated significant excitement with the announcement of the upcoming Version 4.0 of the TMF Reference Model. This model is considered the biggest standard in the industry, especially for TMF, it could be compared to a cookbook for chefs or a music score for musicians. It serves as the recipe to ensure TMFs are well structured and standardized. The last major version of this model was released almost 10 years ago, so the announcement of Version 4.0 for next year was warmly welcomed by all attendees.
New Reference TMF Model
The announcement highlighted that this would be the first TMF digital standard, aiming for all records to be born digital. Increased connectivity between the various systems in use was also emphasized, which is a welcome improvement given the multitude of systems currently in operation. Advancements in the standardization of metadata were discussed, ensuring easier transfer of TMFs between organizations or from CROs to sponsors at the end of studies. This new model is expected to address long-standing needs, such as integrating and standardizing the investigator site file within the TMF. Additionally, the model aims to clarify the filing of new records received from submission in Europe, particularly in relation to the European Clinical Trial Regulation (EU-CTR). These enhancements are highly anticipated and should significantly benefit the industry.
Main Contributors
A call for volunteers was announced, inviting interested individuals to register on the CDISC website. Meetings will be held to gather opinions, with an expectation of active involvement from the TMF community. Ideas can also be submitted through a portal, and several suggestions were made during the conference. One idea was to add a Zone 12 to the TMF for filing system records. Another suggestion was to introduce a program level above the study level, which would allow for the filing of records applicable to multiple studies. Currently, the TMF has 3 levels: study, country, and site. Adding a program level would enhance organization. Additionally, some proposed assigning a risk level to each artifact. These suggestions highlight the community’s engagement and participation for the new version.
Insights From an FDA Inspector: Tips for Future Inspections
During the presentation, it was impressive to learn that over 400 sponsor and CRO inspections were conducted by the FDA over the last 6 years. This highlights a very busy period for the FDA. The presentation by the inspector was particularly interesting, and 3 key takeaways can be shared with our listeners. First, the inspector emphasized the importance of presenting reliable data, which in terms of eTMF, means using a validated system from a qualified vendor and ensuring internal validation. Second, inspectors are increasingly requesting access to the TMF at the start of their inspections. CROs and sponsors need to be prepared with proper access rights and brief training on the system, as inspectors will expect this before being granted access. Finally, there is a growing focus on evidence of sponsor oversight. When sponsors delegate TMF responsibilities to CROs, inspectors may look for evidence that sponsors have been overseeing the CRO’s activities.
The Future of TMF
The risk-based approach is a prominent topic in the industry, and the TMF is no exception. Managing the TMF with this approach is not a one-size-fits-all solution; each organization must determine its own process. This approach should be applied to all steps of TMF management, not just quality control of documents. It can be used for inspection readiness reviews, audit trail reviews, audit trail reviews system validation, and user verification on a monthly or quarterly basis. Focusing on riskier areas at each step is essential.
The future of TMF management will also see an increased presence of artificial intelligence (AI) and machine learning. This technology is already supporting TMF processes, such as document coding and recognizing the correct classification for records entering the TMF. In the future, AI may even perform parts of the quality review or quality control on documents. This is an exciting development.
As we conclude another illuminating episode of Phase Forward, we find ourselves at the crossroads of science and progress. Remember that behind the jargon and statistics, lies stories of unwavering commitment, meticulous observation, and the pursuit of evidence that shapes our understanding of health and disease. Stay at the forefront of knowledge and innovation and follow Phase Forward on your preferred platform. My name is Valerie Coveney. Thank you for joining us. Until next time.
Let’s shape the future of research and make a difference in the industry, gain Innovaderm’s support in your upcoming trial and propel your study to new heights
