This implementation guide is not fully complete.
This implementation guide is based on FHIR Version 4.0.0 and defines the minimum conformance requirements necessary for exchanging clinical trial data. Typically, this exchange will be between a clinical trial site and a clinical trial sponsor.
The FHIR profiles referenced in this guide are closely aligned with the profiles as defined in US Core.
The main distinguishing factor of the profiles contained in this guide is the emphasis on de-identification of patient data, and the usage/adoption of the “Research” FHIR Resources
ResourceSubject
and ResearchStudy
.
This implementation guide describes several use cases and sets search expectations for each.
Additional use cases TBA.