Clinical Trials Registration and Results
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Clinical Trials Registration and Results - WIKI page
The intent of this page is to have a repository of documents or artifacts associated with the Clinical Trials Registration and Results project.
Contents
Project Scope
This document was amended and approved by RCRIM on November 25, 2008
Approved Project Charter on January 21, 2009:
Presentation from the December 10, 2008 - Public Meeting:
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Project Leads
If you have any issues or concerns, please contact one of the following:
Ed Helton (NCI) – heltone2@mail.nih.gov
Tracy Beck (Lilly) - becktj@lilly.com
Kristofer Spahr (Wyeth) - spahrk@wyeth.com
Scott Getzin (Lilly) – sgetzin@lilly.com
Mitra Rocca (Novartis) – mitra.rocca@novartis.com
Project Meeting Minutes
Project Working Documents
Project Team Participation
Overall Project Timeline (subject to change)
September 2009 – Ballot
- Informational level only (providing Storyboards, Interaction and Activity Diagrams, Trigger Events)
January 2010 – Ballot
- DSTU Ballot - Draft Standard for Trial Use (providing all ballot materials including the model)
February 2010 - Begin Testing (likely period - 6 to 12 months)
- Develop Implementation Guide based on Testing
January 2011 – Ballot
- Normative Ballot (providing all ballot materials including the implementation guide)
February 2011 - Begin Implementation and Production Use!!
