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Initiatives related to the CV Domain Analysis Model

  • CV DAM Release 1
  • CV DAM Release 2
  • CV Endpoints

Cardiovascular Domain Analysis Model Project (Release 1)

  • CV DAM Release 1
CV DAM Release 1
  • Project Scope Statement (Approved by CIC September 2008, TSC January 2009)

Cardiovascular Domain Analysis Model Project (Release 2)

Reference Materials

  • Project Scope Statement (Approved by CIC xxx 2010, TSC xxx 2010)
  • ACC Publication on Methodology for the Development of Clinical Data Standards
ACC/AHA 2007 Methodology for the Development of Clinical Data Standards
  • Project Charter
DRAFT Version 0.3

23 July 2009

19 Sep 2009

28 Feb 2011 :*Minutes

14 March 2011

  • Minutes

21 March 2011:*Minutes

28 March 2011:*Minutes

04 April 2011:*Minutes

11 April 2011:*Minutes

18 April 2011:*Minutes

25 April 2011:*Call was cancelled

02 May 2011:*Minutes

09 May 2011:*Minutes

16 May 2011:*Minutes

23 May 2011:*Minutes

06 JUN 2011:*Minutes

13 JUN 2011:*Minutes

20 JUN 2011:*Minutes

27 JUN 2011:*Minutes

11 JUL 2011:*Minutes

18 JUL 2011:*Minutes

25 JUL 2011:*Minutes & files for ballot

01 AUG 2011:*Minutes

08 AUG 2011:*Minutes

22NOV2011:*CV DAM R2.1 Ballot Materials

Cardiovascular Endpoint Initiative (Release TBD)

Building upon the CV DAM activities, the CV Endpoints initiative is working to develop and model the cardiovascular endpoints identified in the FDA Standardized Data Collection for Cardiovascular Trials Initiative. This work is partially funded by the FDA(1R24FD00441101) 2012 to advance the CV endpoints into an implementation-ready standard. The results of this effort are expected to be included in CV DAM Release 3. The work products include:

  • Harmonizing and formalizing the data elements supporting the CV endpoint event clinical concepts
  • Representing, vetting, and publishing them as a CDISC controlled terminology and in a CDISC SDTM Implementation Guide
  • Creating a demonstration dataset illustrating use of the endpoint elements and SDTM model in representing data from multiple clinical research scenarios.

Reference Materials:

04JUL2014:CV ENDPOINT Project Files (Data Element Spreadsheet, Test Data Spreadsheet, Terminology Summary, UML Model)