A TMF is more than a living archive of a clinical trial’s progress; it is a system required by regulatory authorities and is critical for clinical oversight. By developing, implementing and utilizing a sound TMF plan, you will be able to monitor a trial as it advances, ensure high-quality documents and prepare your organization for an inspection at any stage. Additionally, by creating a TMF process, the clinical trial’s sponsors, CRO and site will be able to demonstrate their continued adherence to GCP during the trial.
At the 7th Trial Master File Summit, 40+ speakers will share best practices on a wide range of topics including:
- Quality TMF improvement
- System migration and eTMF implementation.
- Determining and Managing Relevant communications in the TMF.
- Completeness review by the study team and how to streamline this process.
- Maintaining a real time TMF/Implementing Processes to maintain a real time eTMF.
- Senior Management acceptance/funding/championing of eTMF implementation.
- Metrics with CRO and internal staff.
- How to construct a successful TMF team.
- Involving functions in TMF.
- Relevant correspondence, working with CRO partners, Inspection Readiness.
- Document management and processes.
- TMF QC or TMF Process Implementation.
- Inspection Readiness, Metrics, Sponsor Oversight Responsibilities.
- Nothing specific at this time.
- CRO's and their SOP's and standards.
- Study Close-out/Transfer.
- How to set up a successful TMF staff. How to reduce the number of correspondence by downsizing the number of emails.
Top Five Reasons to Attend
- Learn from case studies and best practices for designing and implementing a TMF plan for global trials and inspectional readiness.
- Networking and learn with over 250 TMF colleagues.
- Hear updates on the DIA reference model and MCC’s metrics working group.
- Develop a TMF strategy to ensure proper TMF oversight.
- Explore the latest trends, preparations and expectations for TMF inspections from the FDA, EMA, MHRA and PMDA.