Clinical Research Core Implementation Guide 0.3 - Continuous Build

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This implementation guide is not fully complete.

Overview

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.

Use Cases

This implementation guide describes several use cases and sets search expectations for each.

  • A research study sponsor requests deidentified laboratory data for a patient on a research study
  • A research study sponsor requests deidentified vital signs data for a patient on a research study

Additional use cases TBA.