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.
A rendered version of this implementation guide can be found at https://esource-consortium.github.io/fhir-clinical-research