Submission of Clinical Research Data Contained in EHRs and Other Health IT Systems for General Purpose or Preserving Specific FDA Requirements

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	HL7 Clinical Document Architecture (CDA®), Release 2.0, Final Edition	Final	Production		No	Free	N/A
Standard	CDISC Clinical Data Acquisition Standards Harmonization (CDASH)	Final	Production		No	Free	N/A
Standard	CDISC Operational Data Model (ODM)	Final	Production		No	Free	N/A
Standard	CDISC Protocol Representation Model (PRM)	Final	Production		No	Free	Yes
Standard	CDISC Study/Trial Design Model (SDM)	Final	Production		No	Free	N/A
Standard	IHE- RFD (Retrieve Form for Data Capture)	Final	Production		No	Free	N/A
Standard	CDISC Study Data Tabulation Model (SDTM)	Final	Feedback requested	Feedback Requested	No	Free	No
Implementation Specification	IHE-RPE (Retrieve Protocol for Execution)	Balloted Draft	Production		No	Free	N/A
Implementation Specification	IHE-CRPC (Clinical Research Process Content)	Balloted Draft	Production		No	Free	N/A
Implementation Specification	CDISC Study Data Tabulation Model Implementation Guide	Final	Feedback requested	Feedback Requested	No	Free	No
Implementation Specification	CDISC Therapeutic Area User Guides	Final	Feedback requested	Feedback Requested	No	Free	No
Emerging Standard	CDISC Pharmacogenomics/genetics (PGx) Implementation Guide	Balloted Draft	Feedback requested	Feedback Requested	No	Free	No

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
Stakeholders should review 21CFR11 for more details.	Feedback requested.

Comment

Submitted by cmcdonald on 2018-10-02

On behalf of Wayne Kubick,…

On behalf of Wayne Kubick, CTO of Hl7: "I don’t understand why this section is here at all. It’s not addressing all FDA requirements, and I don’t believe these are currently in use for actual integration. I don’t even understand what the title means. It’s misleading at best and hardly of practical use. The last row on pharmacogenomics was approved, but I don’t see how it’s applicable for this activity, since there’s no use case involving EHRs or Health IT systems. It’s a conversion to CDISC structures and terminologies."

Submitted by shellyspiro on 2018-10-01

Pharmacy HIT Collaborative's Comments on ONC's Proposed 2018 ISA

The Pharmacy HIT Collaborative supports the use of IHE-RFD (Retrieve Form for Data Capture), HL7 Clinical Document Architecture (CDA), Release 2.0, Final Edition, and CDISC Pharmacogeneomics/genetics (PGx) Implementation Guide.