Who’s the Boss? Responsible Parties and the TMF
Anyone around in the ’80s remembers the TV sitcom Who’s The Boss? We would sit around Tuesday nights to see Tony Micelli (played by Tony Danza) and Angela (Judith Light) raise their blended family and keep us on the edge of our seats wondering will they or won’t they end up together. I can just hear the theme song in my head now…
“There’s a time for love and a time for living.
You take a chance and face the wind.
An open road and a road that's hidden,
A brand new life around the bend…”
The more recent show Community had an entire episode dedicated to arguing over who, in fact, is the boss? Angela. The answer is Angela (at least according to Abed). The joke, of course, is that it didn’t matter. It’s just a bygone sitcom. However, when it comes to your TMF, the answer to the same question matters quite a bit!
Depending on the number of sites and duration of the study, a single TMF can have upward of 500,000 documents. Compounded with a sponsor or CRO potentially conducting more than one study? That’s a lot of documentation to get collected, submitted, reviewed, and published! The required documentation can come from many sources, including clinical, regulatory, safety, data management, statistics, medical writing, and product supply, among other contributors. That list also includes any vendors supporting the clinical trial. Many companies grapple with who is really the boss and what authority they have to make sure they are carrying out the necessary activities to ensure things operate smoothly and each “family member” puts things in their correct place.
Many teams struggle defining TMF contributors across all possible parties involved with their operations. Most of the companies we work with have the majority of the departments listed above or more, all with their own way of doing things and often using different systems and/or technologies to house the information. This lack of centralization can hamper a sponsor’s ability to keep the TMF/eTMF as “complete,” “comprehensive,” and “contemporaneous” as required by the regulatory authorities and create risks.
Sponsors, you are Angela. You are the boss.
Sponsors who have faced these challenges realize that being the “TMF Boss” means having effective oversight and holding individual departments and contributors accountable to get the relevant documentation into the TMF as well as identify areas of risk and challenge.
eTMF systems can allow companies to enforce accountability and keep the activity of responsibile parties visible within the eTMF. Surfacing the missing documentation (such as safety reports that went to sites, batch records for investigational product, etc.) can be easily outlined at the kickoff of each study. Relevant department owners are able to work with their teams to have this information indexed in the eTMF, once finalized. Although it is undoubtedly helpful if “the boss” is a TMF expert, many organizations do not have such a person. However, with the help of effective reporting in the form of eTMF dashboards and reports, study teams can supplement expertise with a smartly configured eTMF. It is still encouraged to have an owner with a firm grasp on what is and isn’t critical to the TMF to provide good direction and hold study teams and CROs accountable.
As sponsors and CROs evolve their processes and start to use more advanced eClinical platforms that facilitate virtual creation and sign off of content that can route the documentation directly into the eTMF, this process will become more streamlined. The TMF boss, just like Angela, can manage the TMF household more efficiently. With the cost of running a clinical trial continually increasing, setting meaningful and effective KPIs and milestones can help with your budgetary control, as well as your processes and oversight. The TMF bosses of your organization can then focus on other important activities and have “a brand new life around the bend.”