Semantic Standards Supporting Clinical Data Lifecycle

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Project Title

Investigate how formal semantic standards can support the clinical trial data life cycle from protocol to submission.


Project Team Members

List team leads and team members. Identification of a project manager is recommended.

Affected Stakeholder

Protocol and CSR writers, data managers, statistical programmers,statisticians,reviewers,standards' developers,submission and regulatory functions

Project Meeting Frequency

Definition(s) of Problem/Issue/Challenge

Potential Technological Solution(s)

Other Initiatives that can be leveraged/merged

Recommended Solution(s)

Specific Actions

Deliverables and Dates:

Deliverable Date (ddMONyyyy)
Something Great 14MAR2013
Example Example
Example Example
Example Example



Last revision by DanBoisvert,03/14/2013