Representing Data for Biomedical and Health Services Research Purposes

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology Standards for Data Aggregation through Study Data Tabulation Model (SDTM) (including QRS, Medical Device and Pharmacogenomics Data), Hosted by NCI-EVS	Final	Production		Yes	Free	N/A
Standard	International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Medical Dictionary for Regulatory Activities (MedDRA)	Final	Production		Yes	$	N/A
Standard	Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology for Analysis Dataset Model (ADaM) Hosted by NCI-EVS	Final	Production		Yes	Free	N/A
Standard	Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology for Therapeutic Area Standards	Final	Production		Yes	Free	N/A
Standard	Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology Standards for Data Collection through Clinical Data Acquisition Standards Harmonization (CDASH), Hosted by NCI-EVS	Final	Production		No	Free	N/A
Standard	Clinical Data Interchange Standards Consortium (CDISC) Controlled Terminology for Data Collection for Protocol Hosted by NCI-EVS	Final	Production	Feedback Requested	No	Free	N/A
Standard	Observational Medical Outcomes Partnership (OMOP) Common Data Model (CDM)	Final	Production		No	Free	Yes
Standard	Sentinel Common Data Model	Final	Production		No	Free	N/A
Standard	National Cancer Institute (NCI) Enterprise Vocabulary Service (EVS)	Final	Production		No	Free	N/A
Standard	National Cancer Institute (NCI) cancer Data Standards Repository (caDSR)	Final	Production		No	Free	N/A
Standard	National Cancer Institute (NCI) Metathesaurus	Final	Production		No	Free	N/A
Implementation Specification	HL7® FHIR® Common Data Models Harmonization (CDMH) IG	Final	Production		No	Free	N/A

Limitations, Dependencies, and Preconditions for Consideration	Applicable Value Set(s) and Starter Set(s)
The adoption and federally required levels for using CDISC SDTM for QRS, Medical Devices and Pharmacogenomics purposes vary. Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology developed by ICH, to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorized for use.	Feedback requested.

Limitations, Dependencies, and Preconditions for Consideration

Applicable Value Set(s) and Starter Set(s)

The adoption and federally required levels for using CDISC SDTM for QRS, Medical Devices and Pharmacogenomics purposes vary.
Medical Dictionary for Regulatory Activities (MedDRA) is a standardized medical terminology developed by ICH, to facilitate sharing of regulatory information internationally for medical products used by humans. It is used for registration, documentation and safety monitoring of medical products both before and after a product has been authorized for use.

Feedback requested.

Comment

Submitted by rmcclure on 2017-10-04

I Agree this list needs…

I Agree this list needs better curation. If appropriate it should be reviewed and approved by CDISC folks. What is here is not useful.

Submitted by vojtech_huser on 2017-04-26

medical devices terminology

This page is listing 3 terminologies but the hyperlinks are identical.

The third standard, the linked website does not have any medical devices terminology there. (not even a word device is on the page). The device terminology link should be corrected or the item removed.