An electronic Trial Master File (eTMF) audit trail is information that tracks the creation, modification, and/or deletion of data, including actions at a record or system level from an eTMF system.
It turns out that TMF not only stands for Trial Master File but also Too Much Fun and Too Many Friends! I was fortunate to attend the Fierce EU TMF Summit in person for the first time since 2019, and I was able to catch up with so many friends and industry colleagues.
Representatives from TransPerfect Life Sciences and LMK Clinical Research Consulting recently participated in the Fierce Trial Master File Summit from May 2 to May 4 in New Orleans, Louisiana. While in past conferences, the focus of discussion has been eTMF technology, this most recent conference marked an unexpected paradigm shift toward people- and process-related TMF solutions.
Successful trial master file (TMF) management requires constant and careful attention to each process, procedure, and guideline.
In October, we hosted the first-ever C3 Summit – a virtual event featuring a series of industry expert-led webinars focused on remote trial management and TMF insights. In this blog post, we share a recap of the session Looking Ahead to 2021 - Planning for Uncertainty.
This includes a discussion about what sponsors and CROs anticipate for clinical trials in 2021 after a paradigm shifting year for clinical research
The clinical trial regulatory inspection—among the most pivotal steps in reaching approval—is going through an evolution. Regulatory authorities across the globe are updating their requirements to keep up with new eClinical technology, the increasing complexities of clinical trials, and a new, unexpected variable: COVID-19.
The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company’s own processes.
The 2020 9th Annual TMF Summit placed proper emphasis on these three pillars of TMF management: Quality, Completeness, and Timeliness (real-time inspection readiness). Interestingly, 60% of attendees polled reported they were more concerned with completeness than quality.
The reasons given were:
In part 1 of our vendor oversight series we talked about managing trial master file (TMF) vendors. In practice, this is just one of the many variations of risk management across a clinical trial.
