We are pleased to announce that a revision to the TMF Plan template (v2.0) is now available. This template replaces v1.0 which was originally approved in February 2018.
The revised template was developed across 7 months of work by a cross-industry group led by Jamie Toth (Sr. Director/Global Head, TMF Management & Records, BeiGene). The full team members include:
Jamie Toth, BeiGene (Workstream Lead)
Marion Mays, Independent Consultant
Gillian Gittens, Transperfect
Mabel Ebot, Molecular Partners
Deb Oriez, Sarepta
Twanna Davis, FHI Clinical
Corunna Culver-Windham, Relay Therapeutics
Debra Wells, Novartis
Donna Dorozinsky, Just in Time GCP
Dawn Niccum, Inseption Group
Allison Grosik, Arcus Bio
What is included in this new revision?
Re-arranged the order for better flow, e.g. moved Archiving section to section 10 from section 7
Made all definitions as instructional text to be filled in with company specific definitions
Added tables for both CRO and Sponsor applicable SOPs
Added table for type of training
Removed the RACI and replaced it with an activity table to state who is doing what
Created a new table for vendor types under TMF format/structure and removed Authoritative Sources as a separate section
Added sub-sections where it made sense to do so
Added TMF Transfer agreement text into section 11
A compare document has been created so that you can see the changes made from version 1.0 to version 2.0 and a summary list of the high-level changes has also been made available. You can access the new TMF Plan Template version 2.0 and the related reference documents from our Resources web page (the documents are grouped together under the “TMF Plan Template” tab).
Thank you to the entire TMF Plan Template sub-team for their efforts!
2 thoughts on “CDISC TMF Plan Template v2 Available”
Great Job, Thank you
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