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U.S. Department of Health and Human Services

For Industry

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Study Design Standard

The HL7 Study Design Structured Document Standard (SDSD) captures both structured and unstructured information on the design of an investigational study, i.e. the protocol. Specifically the standard can describe arms, epochs, planned encounters (visits), planned interventions, planned observations (assessments), eligibility criteria, and other important study characteristics in a machine-readable structured format, as well as the unstructured human-readable protocol document.

 

Study Design was designed as an HL7 v3 message. However, during the initial testing period, it was converted to a structured document to better meet long-term requirements. Since the structured document standard has now passed HL7 ballot as a draft standard for trial use (DSTU), the original Study Design message has been withdrawn from further development.

 

Additional background information is available for download.

 

 

CDER Testing of the HL7 Study Design Structured Document Standard

As part of CDER’s ongoing data standards research and development CDER is soliciting volunteers to test the HL7 Study Design Structured Document standard and implementation guide (IG) referenced above. Testing will begin in March 2013 in collaboration with the HL7 study data standards project team. Once available, testers will be able to download a web-based testing tool (xForm) that enables the creation of test files compliant with the standard and IG. No prior knowledge or experience with HL7 or XML is necessary. For those testers without easy access to study protocols, FDA can provide sample study protocols that are in the public domain. The testing outcome is intended to support an operational pilot as a possible next step.

“When available, the test plan will be available for download on this page.”

We hope you will participate in this exciting testing opportunity. Please contact Crystal Allard to register or for more information.