FDA Data Standards Guide

Use	Terminology Standard	Terminology Standards Development and/or Maintenance Organization	Version(s)	FDA Center(s)	Date Support Begins (MM/DD/YYYY)	Examples of Use	Statutory, Regulatory, or Guidance Authority	Information Sources
General Clinical Data	Clinical Data Interchange Standards Consortium (CDISC) Terminology	CDISC/NCI Enterprise Vocabulary Services (EVS)	2011-06-10 or later	CBER, CDER	06/13/2011	Use CDISC Submission values	Standardized Study Data	Index of CDISC SDTM Terminology	Study Data Technical Conformance Guide
General Clinical Data	CDISC Terminology	CDISC/NCI Enterprise Vocabulary Services (EVS)	All Previous Version	CBER, CDER	Ongoing	Use CDISC Submission Values. Do not use for studies initiated after 2011-06-13.	Standardized Study Data	Index of CDISC SDTM Terminology	Study Data Technical Conformance Guide
Non Clinical Data	CDISC Terminology	CDISC/NCI Enterprise Vocabulary Services (EVS)	All Previous Version	CDER		SEND Data	Standardized Study Data	Index of CDISC SEND Terminology	Study Data Technical Conformance Guide
Adverse Events	Medical Dictionary for Regulatory Activities (MedDRA)	Maintenance and Support Services Organization (MSSO)	8 or earlier	CBER, CDER	Ongoing	CDISC AE Domain	Standardized Study Data	MedDRA.org	Study Data Technical Conformance Guide
Adverse Events	MedDRA	MSSO	Current Version	CBER, CDER	08/31/2017	CDISC AE Domain	Standardized Study Data	MedDRA.org	Study Data Technical Conformance Guide
Adverse Events	Event Problem Codes	CDRH/NCI Enterprise Vocabulary Services (EVS)	Latest Version	CDRH	Ongoing	CDISC AE Domain		Medical Devices Event Problem Codes	National Cancer Institute- EVS
Medication	WHO Drug Dictionary [4]	Uppsala Monitoring Centre	Not Specified	CBER, CDER	03/31/2015	Use in SDTM CMDECOD and CMCLAS	Standardized Study Data	WHODrug Dictionary	Study Data Technical Conformance Guide
Medication	WHODrug Global	Uppsala Monitoring Centre	Current Version- B3 format	CBER, CDER	03/15/2018	Use in SDTM CMDECOD and CMCLAS	Standardized Study Data	WHODrug Global	Study Data Technical Conformance Guide
Laboratory Test Name	Logical Observation Identifiers Names and Codes (LOINC)	Regenstrief Institute	Latest Version	CBER, CDER	10/20/2017	Use in SDTM LBLOINC	Standardized Study Data	LOINC	Study Data Technical Conformance Guide
Substances, including active ingredients, active moieties, inactive ingredients	Unique Ingredient Identifiers (UNII)	FDA	Latest Version	CBER, CDER, CFSAN	Ongoing	After UNII is assigned, use UNII in SDTM and SEND TS domain for TSVAL where TSPARMCD is any of the following: TRT, CURTRT, COMPTRT. Use also in CMDECOD.		Substance Registration System- UNII	Study Data Technical Conformance Guide
								Substance Registration System- NLM
Pharmacological Class	MED-RT	Department of Veterans Affairs/Veterans Health Administration designated federal collaborative that is named the "Structured Product Labeling Interagency Expert Panel" (SPLIEP). It includes representation from FDA, VA, NLM, and NCI. It is published through NLM and NCI EVS.	Latest Version	CBER, CDER	Ongoing	Use in SDTM and SEND TS domain for TSVAL where TSPARMCD=PCLAS and TSPARM = Pharmacologic Class. Use FDA established Pharmacologic Class for all FDA approved moieties (see References). Use also in SDTM CMCLAS.	Guidance for Industry: Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information	MED-RT	Study Data Technical Conformance Guide
								Pharmacologic Class
Indication and Usage	SNOMED CT	SNOMED International		CBER, CDER	Ongoing	Use in SDTM TS Domain for TSVAL where TSPARMCD=INDIC and TSPARM=TDIGRP. Use Medical Condition SNOMED terminology subset (see References)	Standardized Study Data	SNOMED CT
Product Labeling Submissions	Structured Product Labeling (SPL)	BGN Dun and Bradstreet FDA HL7 International ISO NCI NLM Regenstrief Institute SNOMED International USP VA	n/a	CDER, CBER, CVM		Downstream use in clinical descision support systems, third party reimbursement systems, and medical information management systems.	Providing Regulatory Submissions in Electronic Format - Content of Labeling	Structured Product Labeling Resources
								SPL Terminology
Postmarketing Safety Reporting - Adverse Events for Medical Devices	Individual Case Safety Report (ICSR)	ICH E2B	R2 R3	CDER, CBER,	June 2014 June 2015	Safety Reporting Portal, eSubmitter and Direct Database to Database	Providing Submissions in Electronic Format-Postmarketing Safety Reports	Individual Case Safety Reports
							Providing Submissions in Electronic Format- Postmarketing Safety Reports for Vaccines	ICSR Terminology