The ability to easily exchange eTMF content between stakeholders can be a significant challenge as each system used to collect the content has its own configuration and export standards. There are many situations where this content needs to be exchanged either during a study or at the end of the study. This is why the TMF reference model steering committee decided to set up a Technical Sub-Group composed of vendors, sponsors and CROs to address these types of issues.
One of the initiatives of the Technical Sub-Group which is currently ongoing is the definition of a mechanism which allows the electronic exchange of eTMF content between stakeholders and systems. We have tried to define something that is flexible and simple to implement which would not require a significant amount of governance. We have also drawn inspiration from eCTD as an example of a content exchange mechanism and CDISC standards for the management of eSignature and audit trail information.
Although this is very much a work in progress, I shared some of the preliminary information about this initiative at the DIA eRegulatory and Intelligence conference last week in Philadelphia. My presentation focused on the need for such a mechanism and illustrated some of the preliminary work that the group has done so far. If you would like to access the slides from my session they are shown below.
We still have quite a way to go so please keep this in mind when looking at the slides. If you are interested in reviewing our work product or participating in the group, please feel free to reach out to me.
Could you see your organization using such a mechanism for exchanging eTMF content? Are there other use-cases that we have not yet identified in the presentation above?
