It is hard to believe the concept of eTMF was really only born in 2010. The professional community was so small that the first-ever eTMF conference only had about 60 attendees. This year’s TMF Summit in Orlando demonstrated incredible growth from the original conference when TMF was in its infancy. This year boasted the largest yet, with over 260 people and multiple tracks highlighting the growing interest in process, people, and technology surrounding all things eTMF. The summit offered a mountain of important eTMF knowledge and insight, but here are just a few of the critical takeaways:
Opportunities for new attendees
As expected, there were plenty of presentations by subject-matter experts demonstrating eTMF adoption. These talks are always packed with great information, but they can be particularly useful for new attendees to the TMF conference, specifically for those in the process of choosing a system or in the process of implementing an eTMF. The presenters offer insight into the ways in which various solutions and approaches can meet challenges and business requirements, which provides the fodder for considering which solution might be a fit for a particular organization.
The importance of prioritizing training
Continuous improvement in all business processes is an easily accepted necessity. In the world of clinical trials, continuous improvement in training could not be more essential. Well-trained staff means process efficiency, diligence (aligned with SOPs, policies, protocol, regulations, etc.), risk reduction, and cost control.
One Sponsor presentation highlighted the need to:
- customize training manuals provided by the vendor as processes evolve, and
- provide hands-on learning with users. This strategy can be effective for teams in a single location, but challenges emerge when teams are operating in multiple locations or are remote and distributed.
Keeping all teams up to date with the latest changes, and providing cost effective, hands-on training are just a couple of the strategic obstacles.
Some of the audience members chimed in and expressed a need for better e-learning courses to facilitate the real process and technology understanding necessary to assure effective adoption. A well-designed e-learning experience is a very practical, trackable, and often engaging means of knowledge transfer. E-learning experiences are also among the most effective ways to train teams operating in multiple locations. The more engaging the experience, the more effective. Gamification has become a staple in corporate training across many industries, and is no less so when applied to training clinical teams. Learners benefit from an element of play in that alleviates the stress and difficulty one can experience when trying to acquire new knowledge.
Effectively capturing study correspondence
Regulatory authorities expect study correspondence to be updated as close to real time as possible to ensure communications are captured in the TMF. IRB/EC, Sponsor, CRO, and site correspondence all needs to be included. Historically, many Sponsors and CROs have struggled to meet this expectation, often adding at the end of a study, putting in a hard to read .PST file, or not adding the correspondence at all. Whether it be an issue of processes or technology, this becomes increasingly urgent and important as regulators become more likely to proactively check that this information is included and up to date. If capturing this correspondence is a challenge to your organization, it is imperative you communicate with trusted colleagues or partners on how you can implement the necessary processes and technology to reduce the risk of easily avoidable findings.
Effective TMF management requires thoughtful engagement
It is true that TMF management is comprised of heavily administrative tasks. However, it is not and should not be allowed to be an endeavor that runs mindlessly in autopilot. In multiple Sponsor and CRO presentations, they challenged everyone to think like an inspector and apply more critical thinking to challenge quality, process, and completeness. The risks of going through the motions and assuming the work is good and correct are too costly to be casually considered. Many companies with the best of intentions will process documents, apply metadata, assure complete pages, check expirations and so on, forgetting that an inspector is going to try to recreate how the study was conducted. Moreover, they will be looking for timely submission to the TMF. Encouraging teams to put on their investigator hat and to think strategically helps create a culture of active engagement in the quality of the TMF. It also helps connect teams to the very real importance and power of their role. TMF teams need to be thinkers as much as they are doers, which seems obvious, but in practice it can be easy for teams to become hyper-focused on the required work streams, forgetting to regularly keep the end in mind. This is not unique to clinical teams. Any heavily procedural and administrative work can lull the best of minds into autopiplot to get the job done.
Mind your GDPR (General Data Protection Regulation)
This regulation is essentially the replacement to the EU’s Safe Harbor policy (Data Protection Directive 95/46/EC). It will go into effect on May 25th of this year, which is just around the corner. This rapidly approaching date prompted discussion around impacts to long-term data storage requirements. Life sciences companies need to ensure their privacy policies, practices, and security requirements are in place before the implementation of this regulation. While many may have plans in place at their respective companies, others were less clear on their company’s preparations and policies.
Establish clear data retention strategy and policy
There was a great panel of sponsors, CROs, and sites discussing some perspectives on the storage and archival of both paper and electronic files. Discussion focused on investigative sites and the EMA requirements of retaining records for 25 years. Some audience members indicated that their site and/or hospital had record retention policies for up to 10 years. This discussion led one individual to share that they destroyed documents in year 11, per hospital policy, only to be asked shortly thereafter to produce those records. Oops!
Interestingly, there was no clear consensus on the “correct” media for storage, which led to the sharing of archive practices and pitfalls. There was one interesting example of an archive stored on CDs while site personnel all used laptops without CD drives, as many modern laptops have phased out CD drives as a standard. Sponsors need to support site personnel by developing proper policies that considers both their longer term business needs, and and is consistent with the sites’ archival requirements.
The ole’ Regulatory Binder (or eISF)
I can’t believe over 20 years since I started in the clinical trial space, these still exist. To me they seem archaic, yet Sponsors and CROs continue to ship physical binders to sites. While the panel at the summit was not large enough to stand as a full sample (only three sites), there was agreement that they preferred not to receive regulator binders. Often, these binders are:
- sent too close to Site Initiation (and too late), so sites have started their own, or
- sometimes sent on CDs with issues of format and an inability to read on the site’s computers
When asked about the use of eISF (as Sponsors and CROs refer to it), there was initially some resistance. As the conversation developed, there was agreement in adoption and adaptation (they have many years ago with EDC), but that careful thought is required for the development and implementation of these systems. The perspective was that this would provide another “portal” that creates administrative efficiencies for the sites and encourages them to work with Sponsors and CROs who take their needs into account. What this all means is that companies with more mature collaboration infrastructure will be more marketable.
A growing conference for a growing professional community
In summary it was another great eTMF conference with strong attendance, more diverse tracks to cater to different needs, more considerations for different areas of focus for each attendee/department represented, and a more diverse pool of CROs and Sponsors than ever before. All involved in eTMF need to work together to streamline processes and strive for effective collaboration and increasingly real-time agility.