The eTMF is the cornerstone of the documentation of clinical trials. The content is created by CRO’s during the clinical trial, inspected by inspectors and finally handed over to the Sponsor. Despite the best effort of the International Conference on Harmonization (ICH) and the Drug Information Association (DIA) there is no TMF or eTMF standardization which could be used 1:1 by CROs, Sponsors and all stake holders. Even worse: This is the description of purpose of the DIA eTMF Reference Model by the DIA:
“The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model is not intended to be taken and used “of-the-shelf” but can be adapted to an electronic or paper TMF, and does not endorse, nor require, any specific technology for application. DIA members and industry members are under no obligation to adopt the TMF Reference Model.”
To summarize it. The TMF Reference Model
- provides a standardized taxonomy and metadata;
- outlines a reference definition of TMF content using standard nomenclature;
- needs to be adapted to the need of the CRO and Sponsor;
- is technology independent;
- does not need to be adopted by the CROs and Sponsors.
Based on the summary above no CRO and no Sponsor is bound to use a specific structure of an eTMF. There is no need that CROs and Sponsors use the standardized taxonomy, metadata, reference definition, standard nomenclature. Its s a good will to use the eTMF reference model.