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.
For each group, click on the group name below to be taken to a link where you can request to join. If you do not currently have a Groups.io account, you will be asked to create an account (groups.io is the tool we use for our teams). If you already have an account, click on the link to login first.
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. Industry members are invite to join the Business Reviewers team.
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.
Identify enhancements/updates to the TMF Reference Model to facilitate easier adoption for medical device and diagnostics trials.
This team will meet regularly to discuss the content of the website and the format, structure etc. Output will be fed to the Technical Administrator who is responsible for actioning updates.
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. To join one of these teams, click on the corresponding link below:
Zone 1 Trial Management
Zone 2 Central Trial Documents
Zone 3 Regulatory
Zone 4 IRB or IEC and other Approvals
Zone 5 Site Management
Zone 6 IP and Trial Supplier
Zone 7 Safety Reporting
Zone 8 Central and Local Testing
Zone 9 Third Parties
Zone 10 Data Management
Zone 11 Statistics