The beginning of November saw the launch of version 3.2.0 of the TMF Reference Model. The updates align with current regulatory guidance and industry best practices, making it easier to organize the TMF Reference Model to suit a company’s own processes.
As someone who has been heavily involved with the TMF Reference Model since 2010 and part of the sub-artifact working group tasked with the review for this new version, I am delighted to see over a year of hard work finally come to fruition. The revision of the sub-artifact column in particular has been an arduous task. I reviewed suggestions and recommendations for document types (both artifacts and sub- artifacts from multiple organizations), with many contributions lists in excess of over 2,890 items! On behalf of the group, I was personally able to combine and analyze all the lists provided into one comprehensive (huge!) list and remove any duplicates so the steering committee could commence review. This was completed in a methodical manner: zone by zone and ensuring each sub-artifact was relevant.
We asked many questions as part of the review:
- What are we trying to identify?
- Do we add a fourth level of filing beyond zone section and artifact?
- What do we mean by sub-artifact?
- What are the similarities and differences between two sub-artifacts present in the same artifact?
The group agreed that we wanted sub-artifacts to be effective for classifying different artifacts that might be filed in the same location to achieve the same point of compliance.
A good example is the artifact 05.02.07 Site Staff Qualifications. This filing location often has many different document types. Even with metadata capturing the names of the site staff, distinguishing the difference between them may still be challenging. Sub-artifacts differentiate between the types of qualification—i.e., a GCP training certificate or an IATA (International Air Transport Association) handling of dangerous goods training certificate.
The results of the full review of the reference model are an expansion of the scope and definition of artifacts and file types. Version 3.2.0 features what we are calling a “super-set” of 612 sub-artifacts that replace “Sub-artifact” and “Alternate name” columns. The new column, called “Recommended sub-artifacts”, is the recommended way to list company-specific records that an organization would expect to file under a given artifact. The good news is that this can be customized (as they are recommendations), thus providing flexibility to help ensure the TMF Reference Model is aligned with companies’ SOPs and compliance needs.
Other changes include:
- A new artifact – 06.05.04 Non-IP Storage Documentation
- Four changes to artifact names
- Changes to filing level – Adding site level to the 01.01.08 Monitoring Plan
- One milestone change
- 22 changes to Artifact Definition/Purpose, Milestones, Glossary, Model Overview, and ICH Code
To review these changes, the TMF Reference Model version 3.2.0 can be found at www.tmfrefmodel.com/resources.
About the TMF Reference Model
The TMF Reference Model provides standardized taxonomy and metadata and outlines a reference definition of TMF content using standard nomenclature. The Model is not intended to be taken and used “off-the-shelf” but to be adapted to an electronic or paper TMF. It neither endorses, nor requires, any specific technology for application. For more information, please visit www.tmfrefmodel.com.
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