On June 16, 2015, the TMF Reference Model (TMF RM) released Version 3 (V3), its first new version since 2013. TMF RM V3 has been enhanced with updates and revisions from scores of participants, many of whom have used V2 of the model to inform their TMF content requirements.
We have worked on multiple engagements which have resulted in our customers extending the specificity of the TMF RM V2 to meet their business needs, and had many Paragon resources at the table supporting the development of V3. Some of the major V3 changes include:
- Sub-artifacts: one significant change in V3 is the addition of a new sub-artifact column. Sub-artifacts are meant to support trial sponsor insights on the types of content managed for artifacts that are more “buckets” of content types than one individual record. Sub-artifacts should increase understanding and flexibility for organizations who manage multiple documents related to one artifact, and can be especially useful when leveraging metadata capabilities in eTMF systems.
In the example below, you can see that the artifact Kick-Off Meeting Material has been related to several sub-artifacts including Agendas, Minutes, Presentation Materials, etc. Sub-artifacts are intended to be descriptive and should be reviewed as suggested examples rather than individually required documents. Each trial sponsor needs to determine the sub-artifacts applicable for their trial’s documentation. As stated in V3: overwrite with your company-specific records.
Sub-artifacts should not be confused with alternate names, which are other commonly used names for artifact types, included to support cross-company clarity when different trial sponsors have used different naming conventions.
Investigator Site File: the coding for artifacts included in Investigator Site Files (ISF) has been simplified and aligned to the codes for sponsor TMF inclusion. An X indicates the artifact would be included in an ISF, and NO indicates that the content is generally not applicable for ISFs. As with all other components of the model, it is important to assess artifact requirements in light of each site’s specific practices and regulatory parameters. At the end of the day, established procedures as well as local and country-specific requirements may necessitate a difference in the specific ISF records to be managed.
Artifact # and Unique ID Number: for most artifacts, V3 artifact numbers have not been changed, and the new artifacts in V3 have been allotted unique new artifact numbers. The few artifact numbers that have changed are due to transfer of the artifact from one zone to another. In all cases where trial sponsors use the TMF RM as a basis for their TMF Master List, we recommend reliance on the artifacts Unique ID Number, as this is the only code that will remain unchanged in TMF RM revisions.
What’s next? Trial sponsors who have aligned to V2 of the TMF RM will need to assess the new version for use in their TMF management practices, and determine impact on both current and new TMFs. Our active engagement in contributing to the development of V3 has given us unique insight to the changes and their potential impact.