I totally agree with Melisa,
I
have to bring this up, something is bothering me, what tomorrow if Oasis is dissolved or taken up by a new company, then we all will be back to Zero, start all over again.
What will be our next step if this happens?
TMF Ref Model is the collaborative work of over 350 people and from ~200
companies, representing Pharma, Biotech, CROs and eTMF vendors, if some of us gets dissolved, it won’t matter TMF Ref Mode will continue as it is a collaborative work of
multi people. As per myself I have switched three companies in the four years , but still have used the TMF Reference Model throughout constantly. It has been extremely helpful.
One request ,
Just keep it as aligned and consistence as possible.
Best Regards
Shah Ashraf
Sr Clinical Document Specialist, Life Sciences Solutions
TransPerfect
Life Sciences
Three Park Avenue
39th Floor
New York, NY 10016
t +1 212.689.5555 ext 1478| f +1 212.689.1059
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From: etmf-comment@lists.oasis-open.org [mailto:etmf-comment@lists.oasis-open.org]
On Behalf Of Maberry, Melissa
Sent: Friday, August 08, 2014 2:16 PM
To: etmf-comment@lists.oasis-open.org
Subject: [etmf-comment] Public review comments for etmf-v1.0-csprd01: 5.1.1.2 Classification Categories Naming Scheme
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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