Why “One eTMF for All” is the wrong goal
[see also part 2 of this series]
The previous articles argued that clinical research may be facing a challenge similar to the one international banking encountered before SWIFT. The industry has become increasingly interconnected, yet much of the operational effort surrounding documentation remains focused on interpretation, reconciliation, and quality control. I also argued that the TMF Reference Model successfully standardised document organisation, but did not attempt to standardise the interpretation of document contents.
In practice, the industry has already begun moving in this direction. Many sponsors increasingly require CROs and, in some cases, investigative sites to operate directly within the sponsor’s eTMF. From the sponsor’s perspective, the rationale is understandable. Visibility improves, governance becomes more centralised, document exchange becomes simpler, and inspection readiness becomes easier to demonstrate.
But is this interoperability or merely centralisation?
In the discussions about these challenges, a recurring proposal often emerged. If fragmentation creates inefficiency, why not place all participants in the same repository? Why not create a single eTMF used by sponsors, CROs, and sites alike? If everyone works from the same system, surely many of today’s coordination problems would disappear.
At first glance, the argument appears compelling. Multiple repositories introduce duplication. Different systems require integration. Independent organisations often maintain overlapping documentation processes. Consolidation therefore seems like a natural path towards simplification.
The difficulty is that history suggests otherwise.
The banking industry faced an almost identical challenge. By the early 1970s, international payments flowed through a complex network of correspondent banks. Transactions frequently crossed multiple jurisdictions and involved several financial institutions before reaching their final destination. Every participant maintained its own systems, its own processes, and its own records. The resulting complexity was substantial.
No serious proposal emerged to solve this by creating a single global ledger.
The reason was straightforward. Banks are independent institutions. They operate under different regulatory regimes, serve different customers, maintain different risk models, and compete with one another. Expecting all participants to abandon their own systems and migrate to a shared repository would have been both impractical and undesirable.
Instead, the industry pursued a different path. Each institution retained ownership of its own records and remained responsible for its own operations. The focus shifted towards creating a common framework for communication between those independent institutions. The ledgers remained local. The communication infrastructure became global.
This distinction remains highly relevant today.
Clinical trials are conducted by independent organisations with distinct responsibilities, governance models, and compliance obligations. Sponsors, CROs, sites, laboratories, and ethics committees do not merely represent different departments within a single enterprise. They are independent participants operating within a shared ecosystem. Each organisation maintains records that it owns, controls, and remains accountable for.
From this perspective, the question becomes whether interoperability requires a shared repository at all.
A sponsor’s eTMF serves an important purpose. It acts as the sponsor’s system of record and provides the sponsor with visibility, governance, and inspection readiness. A site’s repository serves a different purpose. It supports site operations and site accountability. Similar observations apply to CRO systems and other specialised platforms.
The existence of multiple systems is therefore not necessarily a sign of failure. It is often a consequence of accountability.
A sponsor running a single study may reasonably prefer that every participant uses its chosen platform. The benefits are immediate and tangible. An industry running hundreds of thousands of studies over decades, however, must optimise for a different objective. It must optimise for sustainable collaboration between independent participants that will continue working together across thousands of future studies.
In fact, the experience of the other participants is often different. CROs typically work across many sponsors and therefore find themselves operating within multiple sponsor-specific environments. Sites may participate in dozens of studies, each introducing its own systems, workflows, training requirements, and operating conventions. What appears as simplification from the sponsor’s perspective can become fragmentation from the perspective of the wider ecosystem.
The existence of sponsor-specific eTMFs is not, in itself, problematic. The more interesting question is whether this model scales at the level of the industry.
This situation bears a striking resemblance to correspondent banking. Large clearing banks possessed the scale and market position to dictate operational practices to smaller institutions. While these arrangements often solved immediate business needs, they created dependence on the conventions of a particular institution rather than industry-wide interoperability. The industry’s eventual response was not further centralisation, but the creation of common standards and rules that allowed participants to remain independent while interacting consistently.
Clinical research may be facing a similar choice. One path leads towards increasing concentration around sponsor-specific platforms. The other leads towards common infrastructure that allows independent systems to remain independent. Both approaches can function, but they lead to fundamentally different visions of how the industry evolves.
The assumption that interoperability requires all participants to operate within the same repository therefore deserves closer examination. In many industries, interoperability emerged not through consolidation. It emerged through standardisation. Participants remained independent while adopting common methods for exchanging information and coordinating activities.
Email provides an obvious example. No organisation owns all email servers, yet messages move reliably across organisational boundaries because participants agree on how communication should occur. Banking followed a similar path. SWIFT did not become a super central bank, it did not maintain banking accounts, nor did it replace the systems used by those banks. SWIFT, however, did provide a common framework with validation against standards.
This distinction may help explain why many document-management challenges persist despite increasing digitisation. If the underlying challenge is interpretation rather than storage, then moving documents into a common repository may address only part of the problem. Participants may still interpret those documents differently. Quality control may still rely on human review. Reconciliation activities may still be required. Inspection readiness may still depend upon demonstrating how conclusions were reached.
A shared repository may improve accessibility. It does not automatically create a shared understanding.
This observation becomes particularly important as organisations pursue increasingly ambitious digitisation strategies. Discussions often focus on repository consolidation, platform migration, and document exchange. These initiatives may deliver operational benefits, but they do not necessarily establish a common framework for interpreting the information contained within those documents.
Banking eventually discovered that interoperability and centralisation are not the same thing. Clinical research may be approaching a similar realisation.
The challenge is not creating one Trial Master File for everyone. The challenge is enabling independent participants to work from the same understanding while maintaining their own systems of record. The question is not whether the industry needs common system of record. The question is which problems should be solved through common infrastructure and which should remain competitive.
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