Using the Reference Model in Non-Interventional Trials

Question: We are looking for the best way of standardizing our filing system of documents issued during non-interventional trials (e.g. Post-Marketing Surveillance). These trials are getting more and more structured and require a centralized approval for being conducted in a lot of countries. Do you know whether some guidance exists for structuring a TMF for these types of trials?
We are not aware of any guidance specific to filing of documentation for non-interventional trials. Whilst guidelines exist for the ethical conduct of such studies (for example, CIOMS International Ethical Guidelines for Epidemiological Studies), the guidance does not extend to TMF management.
Non-interventional trials are excluded from the requirements of ICH GCP and many other regulatory and legislative requirements that govern interventional trials. However, they should follow relevant national legislation where this exists (ref. Eudralex Volume 9A, Part 1, Section 7.7). For example, in the UK Clause 13 of the ABPI Code of Practice for the Pharmaceutical Industry requires that non-interventional trials comply with certain criteria, including having a written protocol, having written contracts and submission of the protocol to an Ethics Committee. When using the TMF Reference Model as the framework for the design of a TMF model for non-interventional studies, a repeatable corporate model can be created while remaining consistent to this industry model. It is recommended that when establishing a TMF for non-interventional studies, the principles of the TMF Reference Model are followed in terms of terminology and structure, recognizing that modifications to the taxonomy (e.g. removal of unnecessary artifacts) might be required to ensure alignment to standardized business processes.
May 8, 2015

UPDATE: MARCH 19, 2020

A project team has been reviewing the TMF Reference Model for applicability in non-interventional (aka “real world” studies). Their conclusions will be published on this website soon.

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