Difference between revisions of "Drug Safety Content"

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<h2>1. Proposed Profile: <i>{{PAGENAME}}</i></h2>
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Drug Safety Content (DSC) describes the content and format to be used to pre-populate data for safety reporting purposes.  DSC is a content profile that uses transactions described within Retrieve Form for Data-capture (RFD).  
  
<ul>
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==Summary==
    <li> Proposal Editor: <i>[[user: landenbain | Landen Bain, CDISC Liaison to Healthcare ]]</i>
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<p>
    <li> Editor: <i>Michael Ibara, Head of Pharmacovigilance Information Management, Pfizer</i>
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DSC is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research. The purpose of this profile is to support a standard set of data in Continuity of Care Document format which the EHR provides for use in reporting adverse events as it relates to Drug Safety. In addition this profile will reference the ability to convert this output into the ICH E2B(R3) standard.
    <li> Date: <i> January 2008 </i>
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</p>
    <li> Version: <i> 1.0 </i>
 
    <li> Domain: <i> Patient Care Coordination</i>
 
</ul>
 
  
<h2> 2. The Problem </h2>
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__TOC__
<h4>While RFD has simplifies data capture for investigator sites, content profiles will extend its value.</h4>
 
  
<Summarize the integration problem. What doesn’t work, or what needs to work.>
 
  
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==Benefits==
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<p>
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DSC both saves labor and improves the quality of drug safety data. By eliminating duplicate data entry, the use of DSC saves time in the process of completing a drug safety report form. By using existing EHR data to automatically pre-populate the form, DSC eliminates data entry errors, thus improving data quality.
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</p>
  
[edit] 3. Key Use Case
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==Details==
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<p>
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DSC is activated by the Retrieve Form for Data-capture (RFD) profile at the point where RFD retrieves a data safety from a safety reporting system. DSC defines the export document based on HL7's Continuity of Care Document, and provides a mapping to the ICH E2B(R3) standard.
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</p>
  
<Describe a short use case scenario from the user perspective. The use case should demonstrate the integration/workflow problem.>
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==Systems Affected==
 
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<ul>
<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.>
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<li> Electronic Health Record
 
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<li> Safety Reporting System
 
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</ul>
[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"
 
 
 
Category: Templates
 
Views
 
 
 
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Personal tools
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==Specification==
  
    * Landenbain
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'''Profile Status:''' [[Comments| Trial Implementation]] 
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Navigation
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'''Documents:'''
  
    * Main Page
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'' http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_DSC.pdf ''
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:* HL7 Continuity of Care Document
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:* ICH E2B standard
  
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Latest revision as of 13:56, 4 November 2019

Drug Safety Content (DSC) describes the content and format to be used to pre-populate data for safety reporting purposes. DSC is a content profile that uses transactions described within Retrieve Form for Data-capture (RFD).

Summary

DSC is part of a set of profiles that create interoperability between EHRs and specialized research systems, resulting in EHR-enabled research. The purpose of this profile is to support a standard set of data in Continuity of Care Document format which the EHR provides for use in reporting adverse events as it relates to Drug Safety. In addition this profile will reference the ability to convert this output into the ICH E2B(R3) standard.


Benefits

DSC both saves labor and improves the quality of drug safety data. By eliminating duplicate data entry, the use of DSC saves time in the process of completing a drug safety report form. By using existing EHR data to automatically pre-populate the form, DSC eliminates data entry errors, thus improving data quality.

Details

DSC is activated by the Retrieve Form for Data-capture (RFD) profile at the point where RFD retrieves a data safety from a safety reporting system. DSC defines the export document based on HL7's Continuity of Care Document, and provides a mapping to the ICH E2B(R3) standard.

Systems Affected

  • Electronic Health Record
  • Safety Reporting System

Specification

Profile Status: Trial Implementation

Documents:

http://ihe.net/Technical_Framework/upload/IHE_QRPH_Suppl_DSC.pdf


Underlying Standards:

  • HL7 Continuity of Care Document
  • ICH E2B standard