It seems the TMF Reference Model and OASIS eTMF model are not well aligned, specifically, with missing/extra artifacts or ‘preferred terms’. Here are some examples:
- Having all trial IRB documents listed as either a communication, tracking, meeting material and filenotes is not sufficient. There are many key documents (e.g. ethics composition) that are significant enough to warrant their own artifact; otherwise, documents become cluttered and lose their unique identity. With the new MHRA rating of critical TMF findings, this disorganization or lack of clarity would not be acceptable.
- It is not recommended to have IRB documents filed in different primary categories (i.e. trial as 103 and site as 104); a user would want consistency in knowing that a particular number always represents the same content types
- It is not clear why some artifacts are duplicated for primary category 104-Site Management (e.g. IRB and IP), while others exist only in their primary category (e.g. safety)
- Line #124 “Study Team Curriculum Vitae” this new item is not necessary. The existing RM artifacts are sufficient:
| 01.02.02 | Trial Team Curriculum Vitae |
| 05.02.04 | Principal Investigator Curriculum Vitae |
| 05.02.05 | Sub-Investigator Curriculum Vitae |
| 05.02.06 | Other Curriculum Vitae |
| 05.02.07 | Site and Staff Qualification Supporting Information |
Although organizations may adapt the TMF RM to their needs, they know and have documented their deviations from this core model. Introducing another taxonomy, will force significant re-work to
identify gaps and deviations from the core TMF RM, to the organizations adapted version, to the OASIS standard. Fear of change and un-necessary effort will prevent adoption.
As the TMF RM is the collaborative work of over 350 people and from ~200 companies, representing Pharma, Biotech, CROs and eTMF vendors, it is being highly adopted across the industry. Please
remain consistent.
Thanks,
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