An electronic Trial Master File (eTMF) platform serves all the basic functions of a traditional on-site TMF space. Yet an eTMF enhances these basic functions and adds new ones, such as the ability to track access and fine-tune security measures.
Not every eTMF will provide the robust support and compliance measures required. Here are five features a good eTMF system needs.
Role-based access ensures that each eTMF user can access documents according to their need, role and security status — and that documents out of their purview are kept secure as well. Role-based access tools additionally track which users access, create or edit documents and when they perform these interactions.
To evaluate role-based access tools in an eTMF, consider what information each team or role is most likely to need. “When you’re able to pull data that you deal with often in a proactive way, it makes your day-to-day run smoothly,” notes AgencyBloc brand manager Kelsey Rosauer. Saved searches, rolling lists of upcoming tasks or due dates, information sources and other easily accessed data can make work easier for those who use the enterprise content management system.
Regulatory compliance is the paramount purpose of a trial master file. An eTMF can improve compliance in several ways, including:
- Logging dates, times, locations and identities of users and user activities.
- Maintaining legible, standardized originals and logs of edits.
- Comparing documents within the eTMF for discrepancies.
- Requiring information be entered in certain fields to boost completeness.
Users can generate logs and look up documents quickly in order to meet FDA and other demands for evidence of regulatory compliance. They can also submit information electronically when required.
What’s going on in your trial master file? Which tasks have been completed, which documents are done and what tasks remain?
When a TMF was maintained on paper in a physical location, getting a quick one-stop overview of answers to these questions was nearly impossible. Today, an eTMF with real-time dashboards provides that information at a glance.
Dashboards can help show:
- The status of certain types of documentation.
- Where review is required, by whom and whether that review has been completed.
- When documentation is ready for audit or review by regulators.
Keeping a team organized by providing an immediate review of each user’s tasks and goals is one way an eTMF boosts collaboration and supports more efficient and effective work within the trial master file.
Ease of Use and Implementation
Clinical trial teams have long used a physical trial master file. As a result, many are familiar with the analog system. They may have reservations about switching to an eTMF because the eTMF’s unfamiliarity makes the switch feel daunting.
An eTMF with an intuitive user interface and a simple implementation process can help team members overcome their reservations. Ease of use also helps ensure that each team member can use the eTMF’s compliance capabilities to their fullest.
An electronic content management (ECM) system that is easy to use can also help an organization overcome the cultural barriers to adopting new content management technologies. These cultural and behavioral challenges can be significant: In one McKinsey study, 33 percent of respondents said they were the “most significant” in their efforts to change their digital approach. Siloed information, fear of taking risks and difficulty articulating a view of the user were among the top cultural issues, write McKinsey’s Julie Goran, Laura LaBerge and Ramesh Srinivasan.
Every clinical trial team is expected to conform to Good Clinical Practices (GCP) and other regulatory and legal requirements. Yet no two clinical trials are identical in their hypotheses, tools, teams, patients, locations or contexts.
A highly configurable eTMF seeks to bring a set of robust compliance and document management tools to the unique aspects of every clinical trial. Configuration settings allow leadership to control access for greater security, track and log information effectively and stay well-informed throughout the process.
Pressure on clinical trial teams to balance compliant data management against prompt reporting of information has long been a challenge and it continues to rise, write Binny Krishnankutty and fellow researchers in the Indian Journal of Pharmacology. An eTMF helps teams improve their clinical data management, the importance of which cannot be overstated. The authors put it this way: Clinical data management “is a critical phase in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials.”