Who's The Boss? Responsible Parties And The TMF

By Michael Smyth, Division President and Corporate VP, TransPerfect Life Sciences, Trial Interactive

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.

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! 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.