GxP Lifeline
3 Valuable Takeaways from the 2018 TMF U.S. Summit
Clinical professionals from around the U.S. gathered Jan. 16-18 at the TMF U.S. Summit 2018 in Orlando, Fla., to discuss current clinical study trends and some of the pressing issues relating to trial master file (TMF) management. Three underlying themes were prevalent throughout the 7th annual event.
#1 Location, Location, Location
The accessibility and secure storage of up-to-date TMF content is a continual challenge for companies conducting clinical studies. Pharmacyclics’ Alex Markiel and Supriya Shoroff of Sage Therapeutics discussed some of the challenges of TMF management, including a focus on the inherent frustrations of aligning eTMF systems with external information repositories. Typically, the primary concern when connecting systems and repositories is the adequate control of security and access across the TMF. When such a large and diverse volume of documents flows between linked systems, there must be a secure collaboration environment in which content can be shared and exchanged with internal teams and external contributors (i.e., sponsors, CROs, study sites, etc.) in a controlled manner. It is also vital for processes to become established and for personnel to be able to clearly identify where content is stored at all times. That being the case, Markiel and Shoroff urged companies to consider implementing a centralized, comprehensive TMF system to ensure tighter security and access protocols.
Secure collaborative involvement in TMF documents and activities can increase all participating parties’ efficiency while also accelerating a wide variety of processes. Plus, managing TMF information from within a centralized, secure platform streamlines all TMF activities while decreasing the likelihood that critical information will fall through the cracks.
#2 K.I.S.S. (Keep it Simple SMEs)
Presenters at the summit reinforced the wisdom of building TMFs on the backbone of the globally recognized TMF Reference Model, which provides taxonomy and metadata standardization, and as such, clearly defines and outlines the organization of TMF content using standard nomenclature. The current consensus among experts is that structuring activities according to the TMF Reference Model has proven to be the simplest and most effective means for clinical trial subject matter experts (SMEs) to maintain a focus on best practices. Because it is so widely used and recognized by regulatory bodies, the TMF Reference Model is presently the most straightforward and valuable approach to successful TMF preparation. In fact, several presenters warned of various hazards that can occur when organizations overly customize their TMFs and recommended using the TMF Reference Model as a standard index for all TMF-related activities.
The current version of the TMF Reference Model, v3.0, is not substantially different from v2.0, but summit attendees were urged to make the switch to v3.0 if they haven’t already done so in order to stay current with best practices. There is no current date set for the release of a version 4.0 of the model.
#3 To TMF and Beyond…
The TMF world is continuing to grow, accelerate and become more complex, largely due to increasing global regulation. Key regulatory authority requirements for eTMF were discussed in multiple presentations and a few regulatory themes resurfaced frequently throughout the summit:
- TMF records must be readily available upon request
- Inspectors need direct access to the official and complete TMF
- Audit trails must be available in validated systems
- Role-based systems must have an application in place
- TMF documentation on record should be complete, legible, contemporaneous and timely
- Sponsors should regularly check the eTMF
Summit attendees were also encouraged to look for ways to ease the processes involved in periodic quality reviews of the TMF and attempt to improve the tracking of identified issues. An organization’s ability to face these challenges directly is essential to maintaining an inspection-ready TMF.
Tools to Help You Respond to TMF Challenges
While the all the information about operationalizing TMFs and improving TMF activities may have seemed overwhelming to some, the good news is that there are tools and services that are specifically designed to get TMFs up to snuff. There are eTMF software solutions, like those available from MasterControl, that are configured according to the TMF Reference Model and simplify the management of all the TMF documents, tasks, milestones and activities (such as monitoring visits and audits) that are required during the course of a clinical trial. Since it is based on v3.0 of the TMF Reference Model, MasterControl’s eTMF Manager ensures that all interactions in the system remain compliant with current regulatory standards. In addition, it caters to an active eTMF where content is visible at all phases (draft, release and archive) throughout the eTMF. This offers an efficient way to manage the TMF and for sponsors to exercise oversight of the TMF.
Such solutions can provide real-time visibility into the status of all clinical activities and enable both external and internal parties to track the progress of pending, ongoing and completed actions. In fact, MasterControl TMF software solutions feature a unique “GuestConnect” functionality that allows organizations to give practical interaction capabilities—notifications, task assignments, reports, etc.—to authorized sponsors, CROs or other external parties.
Software solutions can be a critical part of maintaining an inspection-ready TMF and driving organizational change that makes TMF management easier. Any system that provides a user-friendly, project plan-oriented view of TMF artifacts and activities ensures increased visibility into the status of all an organization’s TMF efforts.
Looking Forward to the Future of TMF
The next U.S. TMF Summit will take place Jan. 21-23, 2019. For more information about attending the event, visit the TMF Summit website. If you would like to learn more about MasterControl’s eTMF software solutions and services, visit the MasterControl website or contact a MasterControl representative.
Tamara Burch-Williams is a clinical research and biologics professional with over 10 years of experience in research and development, clinical manufacturing, laboratory testing, and infectious disease. She has business process expertise in pharmaceutical and biopharmaceutical integrated services and their respective industries.
Prior to directing her skills to work with technology solutions and services providers, Tamara worked for world-renowned pharmaceutical companies, including Merck, and for private CRO and CMO companies, as well as non-for-profit organizations such as the American Red Cross National Testing Laboratory.
Tamara currently operates as an implementation manager with Professional Services at MasterControl, Inc., where she works with product management, systems development, and services teams to advance solutions designed for the pharmaceutical industry that focus on clinical operations, clinical quality and regulatory affairs.
Prior to joining MasterControl, Tamara cultivated her expertise in clinical, regulatory, and industry disciplines by serving in a variety of professional positions such as a technologist, product manager, production manager and operations manager.
