Drug Safety Content

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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).


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.


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.


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


Profile Status: Trial Implementation



Underlying Standards:

  • HL7 Continuity of Care Document
  • ICH E2B standard