The adoption of v3.0 of the TMF Reference Model across industry has been phenomenal. Data suggests that the Reference Model is being used by the majority of commercial clinical trial sponsors and contract research organisations. But we know that the Model is not perfect and it is only when you start to implement it within an organisation that deficiencies become apparent….. despite our very best efforts to get it right first time!
So we really need to hear from you and incorporate improvements into future versions of the Model. The Steering Committee have recently agreed in principle a new version control process (to be published shortly) whereby we can make small maintenance releases of the Model that have no required impact on existing implementations of the Model but help with understanding and adoption. This will make it easier for us to introduce improvements without having to wait for a major release.
How can you help? We have a simple feedback form on our website to collect three types of comments:
Proposal for a new artifact
If you think the model is completely missing an artifact, let us know. Remember that artifacts do not always correspond to a single document but are best considered as “folders” to file a range of document types that meet a specified regulatory purpose. So please read the definition/purpose in the Model before proposing something new. Additional artifacts have a significant impact to those who have already adopted the Model so we need to be sure your suggestion cannot be met by modifying an existing artifact. If you are proposing the addition of multiple artifacts, please complete a new form for each proposed artifact.
Change existing artifact
Select this option if you think that information in the Model that is associated with an existing artifact needs to be changed. For example, you may think the artifact should be in a different zone. Or you think an artifact is associated with the wrong filing level, or needs the definition/purpose revising. If you are proposing changes to multiple artifacts, please complete a new form for each affected artifact.
Please only use this option if you have a more general comment to make regarding the Model, for example a comment regarding a whole zone. Be as clear as you can and provide a rationale for why you are making the comment.
As the Reference Model is maintained by industry volunteers, we are unable to respond to individual posted comments or to enter into discussions regarding the acceptability of your comments. We may however get in touch with you if we need further clarification and we will review every comment that we receive.