CodeX Implementation Guide: iCAREdata v0.1

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About the ICAREdata® Project

The overall goal of the ICAREdata® project is to support the prospective collection of high quality real-world data, based on mCODE™, to enable clinical oncology research.

The Integrating Clinical trials And Real-world Endpoints data (ICAREdata®) project is a collaboration between The MITRE Corporation, the Alliance for Clinical Trials in Oncology, and the National Cancer Institute (NCI). The project is conducting a study to demonstrate the ability to use high-quality mCODE-based real-world data in a clinical trial setting.

ICAREdata® and mCODE™

This implementation guide intends to cover content necessary for ICAREdata® that is not part of the mCODE™ specification. Implementers should refer directly to mCODE™ for the specification of all mCODE™ elements.

The mCODE™ implementation guide includes information on how to interpret conformance requirements as well as elements marked as "must support". This implementation guide follows those same guidelines.

Structured phrases, mCODE™ and the ICAREData® IG

The ICAREdata® strategy is to collect improved real-world data in a way does not disrupt existing clinical processes and minimizes burden to the provider while enabling the collection of complete, accurate, and computable data. ICAREdata® questions are answered by clinicians with the results appearing as structured (#hashtag) phrases in the clinical note.

ICAREdata® structured phrases questions and value sets are intended to be mapped to FHIR resources compliant with the requirements specified in the mCODE™ and ICAREdata® implementation guides. This includes mapping 1) the ICAREdata® question to the appropriate FHIR resource and element, and 2) the associated value to the appropriate vocabulary defined in the specification.

The figure below illustrates how ICAREdata® structured phrases relate to FHIR profiles and implementation guides.

ICAREdata® and FHIR

For details on mapping guidance for specific ICAREdata® structured phrases, please consult ICAREdata® to FHIR mapping guidance.

Contact Information

For inquiries regarding ICAREdata® Project, contact Miranda Chan.

For questions or issues related to this implementation guide, please use our SHR Core Models JIRA issue tracker.

For questions or issues regarding the content of mCODE&trade implementation guide, please use the mCODE™ JIRA issue tracker.


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