It seems the TMF Reference Model and OASIS eTMF model are not well aligned, specifically, with the numbering schema. The category code doesn’t match the RM artifact #, as OASIS primary categories are 3-digit, whereas the corresponding RM zone is 2-digit;
additionally, the sequencing is not matched. For example, TMF Plan in the OASIS model is T100.10.10,
while it is 01.01.01 in the TMF RM.
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; abandoning
already existing and asking the industry to adopt new taxonomy is not recommended. Please remain consistent.
Thanks,
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