The TMF Reference Model Project comprises a number of working groups. Most of the groups have a defined set of deliverables and will come to a close once those deliverables have been finalised and published, whilst other groups remain ongoing. If you have the time to get involved in the project, please read through these brief descriptions of our activities and identify where you can best make a contribution. It is important to understand that we need individuals who have the time and enthusiasm to contribute on a regular basis. If you will struggle to make this time available, perhaps it is best just to keep in touch as a subscriber.
The following teams would welcome new members:
Exchange Mechanism Team:
To define a standard and simple mechanism for the transfer of eTMF content, using existing standards where appropriate.
Whilst a definition of sub-types is provided in the RM, the concept is not well understood and variously interpreted. Develop clear guidance on the purpose and use of sub-types within the RM and expand on the examples included in the Model.
Annual Survey Team:
Revise annual survey content to accommodate any additional requirements. Conduct the survey. Publish the results. This team is active each year that the survey is published.
Implementation Toolkit Team:
Review and revise the existing Reference Model User Guide. Expand to develop a more extensive implementation toolkit.
Define clearly why there might be issues adopting the Reference Model with country-specific requirements. Define deliverables to facilitate TMF completeness compliant with country-specific requirements.
Filter the artifact requirements of the Reference Model for a single-site study. Make the filtered list available as a stand-alone template.
Non-interventional / Observational Studies:
Based on relevant guidance and best practice, identify existing Reference Model artifacts that would be expected for observational studies and any additional artifacts not already included in the Reference Model.
Identify enhancements/updates to the TMF Reference Model to facilitate easier adoption for medical device and diagnostics trials.
Due to the significant differences between requirements for GCP in Japan and other ICH territories, we have a group that is looking at how the TMF Reference Model can be better adapted for compliance with Japanese regulations.
There is a team for each of the Reference Model Zones…. so 11 zone teams in total. If you consider yourself experienced – maybe even an expert! – in one of the zones, please consider joining a zone team. The Change Control Board refers change requests and other artifact queries to the relevant zone team. The zone teams usually only meet when they have specific queries that need discussion for their zone.