Drug Safety Content

1. Proposed Profile: Drug Safety Content

• Proposal Editor: Landen Bain, CDISC Liaison to Healthcare
• Editor: Michael Ibara, Head of Pharmacovigilance Information Management, Pfizer
• Date: January 2008
• Version: 1.0
• Domain: Patient Care Coordination

2. The Problem

While RFD has simplifies data capture for investigator sites, content profiles will extend its value.

<Summarize the integration problem. What doesn’t work, or what needs to work.>

[edit] 3. Key Use Case

<Describe a short use case scenario from the user perspective. The use case should demonstrate the integration/workflow problem.>

<Feel free to add a second use case scenario demonstrating how it “should” work. Try to indicate the people/systems, the tasks they are doing, the information they need, and hopefully where the information should come from.>

[edit] 4. Standards & Systems

<List existing systems that are/could be involved in the problem/solution.>

<If known, list standards which might be relevant to the solution>

[edit] 5. Discussion

<Include additional discussion or consider a few details which might be useful for the detailed proposal>

   <Why IHE would be a good venue to solve the problem and what you think IHE should do to solve it.> 
   <What might the IHE technical approach be? Existing Actors? New Transactions? Additional Profiles?> 
   <What are some of the risks or open issues to be addressed?> 

<This is the brief proposal. Try to keep it to 1 or at most 2 pages>

<Delete this Category Templates line since your specific Profile Proposal page is no longer a template.> Retrieved from "http://wiki.ihe.net/index.php?title=Brief_Proposal_Template"

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