Instructions for use of the FDA Data Standards Catalog

The FDA Data Standards Catalog (Catalog) lists the data standards and terminologies that FDA supports for use in regulatory
submissions to better enable the evaluation of safety, effectiveness, and quality of FDA-regulated products. In addition, the FDA
has the statutory and regulatory authority to require certain standards and terminologies and these are identified in the Catalog
with the date the requirement begins and, as needed, the date the requirement ends, and information sources. The submission
of data using standards or terminologies not listed in the Catalog should be discussed with the Agency in advance. Where the
Catalog expresses support for more than one standard or terminology for a specific use, the sponsor or applicant may select one
to use or can discuss, as appropriate, with their review division.

Sponsors and applicants should review the Catalog terms below, as well as any references associated with specific standards or
terminologies.

Column headings used in the Data

Complete description of the columns in
Exchange Standards and Terminology
the Data ExchangeStandards and Terminology Standards tabs
Standards tabs
Use This describes the type of data the standard is used for.

This is a standard for the exchange of data between computer systems.

Data Exchange Standard Generally, the specification that has been developed by a standards development
organization.

An exchange format standard specifies a particular way that information is

Exchange Format
encoded in a computer file.

Standards Development Organization The organization developed and maintains the standard or terminology

For the purposes of this catalog, “supported” means the receiving FDA Center has
Supported Version established processes and technology to support receiving, processing, reviewing,
and archiving files in the specified standard.

This lists the version of the implementation guide that is supported by FDA. The
Implementation Guide Version
implementation guide provides additional instruction for the standard.

This identifies which centers (e.g., CBER, CDER, CDRH, CSFAN, CVM, CTP,OC,
FDA Center
ORA, NCTR) in FDA use the supported standard.

This is the date when sponsors can start using the standard or terminology.
Date Support Begins "Ongoing" means that FDA supports the listed standard for electronic submissions
as of the initial Catalog release date, 6/13/2011.

If a study started before the support ends date, a study can continue to use this
specified standard. If a study starts after the support ends date, a study can
NO longer use the specified standard. Sponsors cannot use the standard or
Date Support Ends
terminology after this date. Generally, a waiver process may be available.
Sponsors and applicants should consult with their review division. An empty field
in this column means that a support end date has not been established.

Date Requirement Begins
Date Requirement Ends
Statutory and Regulaory Authority
Information Sources
This is the date when the requirement to use a specific version of a standard or
terminology begins for any study that starts after the 'Requrement Begins' date'.
After this date, sponsors and applicants must use the indicated standard or
terminology in submissions as per statute or regulation. An empty field in this
column means that a requirement date has not been established.
If a study started on the requirement ends date, a study can continue to use this
specified standard. If a study starts after the requirement ends date, a study
can NO longer use the specified standard.The standard or terminology can no
longer be used to submit data for studies starting after this date. Generally, a
waiver process may be available. Sponsors and applicants should consult with
their review division. An empty field in this columns means that a support end date
has not been established.
Reference documents or webpage that provides information on the FDA's
authority to request the submission of data in specified formats.
Additional information to assist sponsors and applicants in using the listed data
standards and terminologies
 FDA Data Standards Catalog v7.3 (09-14-2021) - Supported and Required Standards

For full description of column headings, see Instr.& Column Descriptions tab
Date Support Date Requirement
Standards Supported Date Support Date Requirement
Data Exchange Exchange Begins Begins Statutory, Regulatory, or Guidance
Use Development Supported Version Implementation FDA Center(s) Ends Ends Information Sources
Standard Format (MM/DD/YYYY) (MM/DD/YYYY) Authority
Organization (SDO) Guide Version (MM/DD/YYYY) (MM/DD/YYYY)
[10] [11]

Regulatory M2 eCTD: Electronic

Applications (IND, Common Technical
Regulatory Submissions in Electronic Format Electronic Submissions-Electronic Common Technical Document (eCTD)
NDA, ANDA, BLA, Electronic Extensible Document
master files) Common Technical Markup Language International Council for Specifications 05/05/2017 [5]
Document (eCTD) (XML) Harmonisation (ICH) 3.2.2 CDER, CBER 06/01/2008 05/05/2018 [6]

Product Labeling
Providing Regulatory Submissions in Electronic
Structured
Format - Drug
Product
Establishment
Labeling (SPL)
Registration
Implementation
and Drug
Guide
Listing
with Validation Procedures
Submissions
Structured Product 04/01/2005 [3]
Labeling (SPL) XML Health Level 7 (HL7) Release 5 CDER, CBER Ongoing 12/11/2003 [4]

Structured Product
Labeling (SPL)
Postmarketing
Implementation Guide
Safety Reporting-
with Validation Electronic Submission of Lot Distribution Reports FDA Structured Product Labeling Resources
Lot Distribution
Procedures Version 1
Reports
Revision
201412101457
SPL XML HL7 Release 5 CBER 06/10/2015 n/a 06/10/2015 n/a

Global Unique Device

Identification
Database (GUDID)
Postmarket
Release 1.2.3
Reporting –
Health Level 7 (HL7)
Submission to Final Rule for UDI GUDID Health Level 7 (HL7) Structured Product Labeling (SPL)
Structured Product
Global UDI
Labeling (SPL)
Database (GUDID)
Implementation
Specification
Version 1.3
SPL XML HL7 Release 5 CDRH 1/13/2015

Postmarketing
Safety Reporting -
Postmarketing Safety Reports: Electronic Submission
HL7
Requirements
ICSR Files: Complete Packet eMDR
Adverse Events for
Medical Devices Individual Case
Safety Report
(ICSR) XML HL7 Release 1 N/A CDRH Ongoing
Postmarketing
Safety Reporting-
Adverse Events for Guidance for Submission of Veterinary AER Adverse Drug Experience (ADE) Reports
Veterinary Adverse Event Reporting for Manufacturers
Animal Drugs
(ICSR)
ICSR XML ISO/HL7 Release 2 N/A CVM Ongoing
Postmarketing
Safety Reporting -
Adverse Events for Postmarketing Safety Reports: Electronic Submission
FDA Adverse
Requirements
Events Reporting System (FAERS) Electronic Submissions
Drugs and
Biologics (ICSR)
ICSR XML ICH E2B Release 2 ICH E2B CDER, CBER Ongoing

ICH E2B (R3) IG July

Postmarketing
2013 and CBER
Safety Reporting-
Technical Postmarketing Safety Reports: Electronic Submission Requirements
FDA Individual Case Safety Reports
Adverse Events for
Specifications
Vaccines
Document
ICSR XML ISO/HL7 Release 2 CBER 06/10/2015 n/a 06/10/2015 n/a
Postmarketing
Safety Reporting - International
Periodic Reports Conference on Postmarketing Safety Reports: Electronic Submission
FDA Adverse
Requirements
Events Reporting System (FAERS) Electronic Submissions
Harmonisation
for Drugs and
Biologics (ICH)
eCTD XML ICH 3.2.2 N/A CDER, CBER Ongoing

Documents Portable Document CBER, CDER, For CDER and CBER only: Portable Document Format (PDF) Specifications
Format CFSAN, CDRH,
(PDF) PDF Adobe 1.4-1.6 N/A CVM Ongoing

Documents For CDRH only: eCopy Program for Medical Device Submissions
CBER, CDER,
PDF PDF Adobe 1.7 N/A CDRH 11/20/2012

Clinical and Non-

SAS Technical
Clinical study data Standardized Study Data For CDER and CBER only: Technical Conformance Guide
Support TS-140 12/17/2016 [1]
sets - Transport
SAS (XPORT) XPT SAS 5 CDER, CBER Ongoing 12/17/2017 [2]
 FDA Data Standards Catalog v7.3 (09-14-2021) - Supported and Required Standards

For full description of column headings, see Instr.& Column Descriptions tab
Date Support Date Requirement
Standards Supported Date Support Date Requirement
Data Exchange Exchange Begins Begins Statutory, Regulatory, or Guidance
Use Development Supported Version Implementation FDA Center(s) Ends Ends Information Sources
Standard Format (MM/DD/YYYY) (MM/DD/YYYY) Authority
Organization (SDO) Guide Version (MM/DD/YYYY) (MM/DD/YYYY)
[10] [11]

Clinical and Non-

SAS Technical For CDRH only: eCopy Program for Medical Device
Clinical study data Standardized Study Data
Support TS-140 CDRH, CFSAN, Submissions
sets - Transport
SAS XPORT XPT SAS 5 CVM Ongoing

Sharing Structured
W3C - XML Technology
Information CBER, CDER,
XML W3C 1.0 CDRH Ongoing

Analysis program
ANSI
files CBER, CDER,
ASCII ANSI CDRH Ongoing

Study Data Clinical Data Standardized Study Data

Clinical study
Tabulation Model XPT Interchange Standards 1.1 3.1.1 CDER, CBER Ongoing 01/28/2015 CDISC.org - SDTM
datasets
(SDTM) Consortium
(CDISC) Study Data Technical Conformance Guide

Clinical study 03/15/2019 [1] 12/17/2016 [1] 03/15/2019 [1] Standardized Study Data CDISC.org - SDTM
datasets SDTM XPT CDISC 1.2 3.1.2 CDER, CBER 10/30/2009 03/15/2020 [2] 12/17/2017 [2] 03/15/2020 [2]
Clinical study Version 3.1.2 03/15/2019 [1] 12/17/2016 [1] 03/15/2019 [1] Standardized Study Data CDISC.org- SDTM
datasets SDTM XPT CDISC 1.2 Amendment 1 CDER, CBER 08/07/2013 03/15/2020 [2] 12/17/2017 [2] 03/15/2020 [2]

Clinical study
12/17/2016 [1] Standardized Study Data CDISC.org - SDTM
datasets
SDTM XPT CDISC 1.3 3.1.3 CDER, CBER 12/01/2012 03/15/2021 12/17/2017 [2] 03/15/2021
Clinical study
03/15/2018 [1] Standardized Study Data CDISC.org- SDTM
datasets
SDTM XPT CDISC 1.4 3.2 CDER, CBER 08/17/2015 03/15/2019 [2]
Clinical study
Standardized Study Data CDISC.org- SDTM
datasets
SDTM XPT CDISC 1.7 3.3 CDER, CBER 03/15/2021 03/15/2023
Animal Rule study
3/15/2022 [1] Standardized Study Data CDISC.org- SDTM
datasets
SDTM XPT CDISC 1.8 SENDIG-AR v1.0 CDER 03/15/2020 3/15/2023 [2]
Clinical study
Analysis Data 03/15/2019 [1] 12/17/2016 [1] 03/15/2019 [1] Standardized Study Data CDISC.org - ADaM
datasets
Model (ADaM) XPT CDISC 2.1 1.0 CDER, CBER Ongoing 03/15/2020 [2] 12/17/2017 [2] 03/15/2020 [2]
Clinical study
03/15/2019 [1] Standardized Study Data CDISC.org - ADaM
datasets
ADaM XPT CDISC 2.1 1.1 CDER, CBER 03/15/2018 03/15/2020 [2]

Animal study Standard for

Exchange of Standardized Study Data CDISC.org - SEND
datasets
Nonclinical Data 03/15/2019 [1] 12/17/2016 [1] 03/15/2019 [1]
(SEND) XPT CDISC 1.2 3.0 CDER 06/13/2011 03/15/2020 [2] 12/17/2017 [2] 03/15/2020 [2]

Animal study
Standardized Study Data CDISC.org - SEND
datasets 03/15/2019 [1]
SEND XPT CDISC 1.5 3.1 CDER 08/21/2017 03/15/2020 [2]

Animal study
Standardized Study Data CDISC.org - SEND
datasets
SEND XPT CDISC 1.5 3.1 CBER 03/15/2021 03/15/2023

Nonclinical study
Standardized Study Data CDISC.org - SEND
datasets 03/15/2023 [1]
SEND XPT CDISC 1.6 SENDIG-DART v1.1 CDER 03/05/2021 03/15/2024 [2]

Study data
Standardized Study Data CDISC.org - Define-XML
definition 12/17/2016 [1]
Define XML CDISC 1.0 N/A CDER, CBER Ongoing 03/15/2018 12/17/2017 [2] 03/15/2018

Study data
Standardized Study Data CDISC.org - Define-XML
definition 12/17/2016 [1]
Define XML CDISC 2.0 N/A CDER, CBER 08/07/2013 12/17/2017 [2]

Study data
Standardized Study Data CDISC.org - Define-XML
definition
Define XML CDISC 2.1 N/A CDER, CBER 03/15/2021 03/15/2023
 FDA Data Standards Catalog v7.3 (09-14-2021) - Supported and Required Standards

For full description of column headings, see Instr.& Column Descriptions tab
Date Support Date Requirement
Standards Supported Date Support Date Requirement
Data Exchange Exchange Begins Begins Statutory, Regulatory, or Guidance
Use Development Supported Version Implementation FDA Center(s) Ends Ends Information Sources
Standard Format (MM/DD/YYYY) (MM/DD/YYYY) Authority
Organization (SDO) Guide Version (MM/DD/YYYY) (MM/DD/YYYY)
[10] [11]

Structured Product
Structured Product Labeling (SPL) Implementation Guide
SPLIMAGE
with Validation
File Specification
Proceduresv3.02
(Section 3.2.12, 3.2.19, and Table 4)
Labeling
CDER, CBER,
SPL Image JPG, XML FDA and NLM 3.02 N/A CVM 03/21/2012 03/21/2012 [7]

International Institute of
High-througput HTS
Electrical and CDER, CBER,
Sequencing (HTS) BioCompute Bioinformatics Current Version N/A 03/15/2021 N/A https://standards.ieee.org/standard/
Electronics Engineers CFSAN
Data workflows
(IEEE)

Notes:
[1] For NDAs, ANDAs, and certain BLAs. See section II.A of the Providing Regulatory Submissions In Electronic Format — Standardized Study Data guidance document
[2] For certain INDs. See section II.A of the Providing Regulatory Submissions In Electronic Format - Standardized Study Data
[3] Providing Regulatory Submissions in Electronic Format - Content of Labeling
[4] The requirements of the electronic labeling rule can be found in § 314.50(l) for NDAs, § 314.94(d) for ANDAs, § 601.14(b) for BLAs, and § 314.81(b) for annual reports to marketing applications. The effective date of the rule was June 8, 2004.
[5] For NDAs, ANDAs, and BLAs. See section B of the Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submission Using the eCTD Specifications guidance document
[6] For Commercial INDs and Master Files. See section B of the Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submission Using the eCTD Specifications guidance document
[7] The pill image is optional, but it is highly recommended to address numerous potential patient safety issues. Also see Federal Register Volume 76, Number 99, and Federal Register Volume 79, Number 182 as background.
[8] " Ongoing"- Prior to the posting of a FDA Data Standards Catalog in 2011, FDA supported a number of data standards and there was no specific date when support began for some of these standards. As a result, the support status of “Ongoing” was entered for “Date Support Begins”.
[9] The simplified TS.xpt is a specific implementation of the CDISC SDTM standard being utilized by FDA (CDER and CBER) to establish the study start date or indicate that the study is exempted for evaluation by the Study Data Technical Rejection Criteria (TRC). For specifics on how to implement the simplified TS.xpt, please refer to the Study Data Technical Conformance Guide
[10] Please see the Study Data Technical Conformance Guide for clarification regarding when electronic standardized study data are required as part of a submission to address a public health emergency declared by the Secretary of Health and Human Services in accordance with section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)).
[11] Please see the Study Data Technical Conformance Guide for clarification regarding when electronic standardized study data are required for particular types of studies, such as pilot studies and failed studies submitted to ANDAs.
 FDA Data Standards Catalog v7.3 (09-14-2021)

For full description of column headings, see Instr. & Column Descriptions tab

Date
Terminology Standards Date
Date Support Date Support Requirement
Terminology Development and/or Requirement Statutory, Regulatory, or
Use Version(s) FDA Center(s) Begins Ends Begins Examples of Use Information Sources
Standard Maintenance Ends Guidance Authority
(MM/DD/YYYY) (MM/DD/YYYY) (MM/DD/YYYY)
Organization (MM/DD/YYYY)
[10] [11]

Clinical Data
Interchange
General Clinical Standards CDISC/NCI Enterprise 2011-06-10 or 12/17/2016 [1]
CBER, CDER 06/13/2011 Use CDISC Submission values Standardized Study Data Index of CDISC SDTM Terminology Study Data Technical Conformance Guide
Data Consortium Vocabulary Services (EVS) later 12/17/2017 [2]
(CDISC)
Terminology

General Clinical Use CDISC Submission Values.

CDISC CDISC/NCI Enterprise All Previous
Data CBER, CDER Ongoing Do not use for studies initiated after Standardized Study Data Index of CDISC SDTM Terminology Study Data Technical Conformance Guide
Terminology Vocabulary Services (EVS) Version
2011-06-13.

CDISC/NCI Enterprise All Previous

Non Clinical Data CDISC CDER SEND Data Standardized Study Data Index of CDISC SEND Terminology Study Data Technical Conformance Guide
Vocabulary Services (EVS) Version
Terminology

Medical Dictionary
Maintenance and Support
Adverse Events for Regulatory 03/15/2019 [1] 12/17/2016 [1] 03/15/2019 [1]
Services Organization 8 or earlier CBER, CDER Ongoing CDISC AE Domain Standardized Study Data MedDRA.org Study Data Technical Conformance Guide
Activities 03/15/2020 [2] 12/17/2017 [2] 03/15/2020 [2]
(MSSO)
(MedDRA)

Adverse Events 03/15/2019 [1]

MedDRA MSSO Current Version CBER, CDER 08/31/2017 CDISC AE Domain Standardized Study Data MedDRA.org Study Data Technical Conformance Guide
03/15/2020 [2]

Event Problem CDRH/NCI Enterprise

Adverse Events Latest Version CDRH Ongoing CDISC AE Domain Medical Devices Event Problem CodesNational Cancer Institute- EVS
Codes Vocabulary Services (EVS)

WHO Drug 03/15/2018 [1] Use in SDTM CMDECOD and

Medication Uppsala Monitoring Centre Not Specified CBER, CDER 03/31/2015 03/15/2019 [5] 03/15/2019 [5] Standardized Study Data WHODrug Dictionary Study Data Technical Conformance Guide
Dictionary [4] 03/15/2019 [2] CMCLAS

Current Version- Use in SDTM CMDECOD and

Medication WHODrug Global Uppsala Monitoring Centre CBER, CDER 03/15/2018 03/15/2019 Standardized Study Data WHODrug Global Study Data Technical Conformance Guide
B3 format CMCLAS

Logical
Observation
03/15/2020 [1]
Laboratory Test Identifiers Names Regenstrief Institute Latest Version CBER, CDER 10/20/2017 Use in SDTM LBLOINC Standardized Study Data LOINC Study Data Technical Conformance Guide
03/15/2021 [2]
Name and Codes
(LOINC)

After UNII is assigned, use UNII in

Substances, SDTM and SEND TS domain for Substance Registration System- UNII
including active Unique Ingredient 12/17/2016 [1] TSVAL where TSPARMCD is any
CBER, CDER,
ingredients, active Identifiers FDA Latest Version Ongoing 12/17/2017 [2] of the following: TRT, CURTRT, Study Data Technical Conformance Guide
CFSAN
moieties, inactive (UNII) 05/06/2004 [3]
COMPTRT. Use also in
ingredients Substance Registration System- NLM
CMDECOD.

Department of Veterans
Affairs/Veterans Health
Use in SDTM and SEND TS
Administration designated MED-RT
domain for TSVAL where
federal collaborative that is
TSPARMCD=PCLAS and
named the "Structured
12/17/2016 [1] TSPARM = Pharmacologic Class.
Pharmacological Product Labeling
MED-RT Latest Version CBER, CDER Ongoing 12/17/2017 [2] Use FDA established Guidance for Industry: Labeling for Human Prescription Drug and Biological
Study
Products-Determining
Data Technical Conformance
EstablishedGuide
Pharmacologic Class for Use in the Highlights of Prescribing Information
Class Interagency Expert Panel"
05/06/2004 [3] Pharmacologic Class for all FDA
(SPLIEP). It includes
approved moieties (see
representation from FDA,
References). Use also in SDTM Pharmacologic Class
VA, NLM, and NCI. It is
CMCLAS.
published through NLM
and NCI EVS.

Use in SDTM TS Domain for

TSVAL where TSPARMCD=INDIC
12/17/2016 [1] and TSPARM=TDIGRP. Use
Indication and SNOMED CT SNOMED International CBER, CDER Ongoing Standardized Study Data SNOMED CT
12/17/2017 [2] Medical Condition SNOMED
Usage
terminology subset (see
References)

BGN
Dun and Bradstreet
FDA Structured Product Labeling Resources
HL7 International Downstream use in clinical
ISO descision support systems, third
Product Labeling Structured Product CDER, CBER,
NCI n/a April 2005 party reimbursement systems, and Providing Regulatory Submissions in Electronic Format - Content of Labeling
Submissions Labeling (SPL) CVM
NLM medical information management
Regenstrief Institute systems.
SNOMED International
USP
VA
 FDA Data Standards Catalog v7.3 (09-14-2021)

For full description of column headings, see Instr. & Column Descriptions tab
BGN
Dun and Bradstreet Date
Terminology Standards Date
FDA Date Support Date Support Requirement
Terminology Development and/or Requirement Statutory, Regulatory, or
Use HL7 International Version(s) FDA Center(s) Begins Ends Begins Examples
Downstream useofinUse
clinical Information Sources
Standard Maintenance Ends Guidance Authority
ISO (MM/DD/YYYY) (MM/DD/YYYY) (MM/DD/YYYY) descision support systems, third
Product Labeling Structured Product Organization CDER, CBER, (MM/DD/YYYY)
NCI n/a [10] 2005
April [11] party reimbursement systems, and Providing Regulatory Submissions in Electronic Format - Content of Labeling
Submissions Labeling (SPL) CVM
NLM medical information management
Regenstrief Institute systems.
SNOMED International
USP SPL Terminology
VA

Providing Submissions in Electronic Format-Postmarketing

Individual Case Safety
Safety
Reports
Reports
Postmarketing
Individual Case
Safety Reporting - R2 June 2014 Safety Reporting Portal, eSubmitter
Safety Report ICH E2B CDER, CBER, September 2015
Adverse Events for R3 June 2015 and Direct Database to Database
(ICSR)
Medical Devices

Providing Submissions in Electronic Format- Postmarketing

ICSR Terminology
Safety Reports for Vaccines

Geopolitical Entity
Country Codes Working
Countries (e.g.,
Geopolitical Group, National Center for Any database, report, or
United States) and United States Public Law 80-242 (1947) GENC Terminology
Entities, Names, Geospatial Intelligence submission that stores and/or
their Principal Current Version FDA Center(s) 12/17/2015 12/17/2020
and Codes Standards (NCGIS), displays Countries and their
Subdivisions (e.g.,
(GENC) National Geospatial- Principal Subdivisions
Maryland)
Intelligence Agency (NGA)
NSG Documents Registry

Structured Product Labeling Implementation Guide with Validation Procedures

Drug
Establishment
Registration and Inactive Ingredients Database,
Unified Codes for Providing Regulatory Submissions in Electronic Format- Drug Establishment Registration and Drug Listing
Drug Listing, Regenstrief Institute July 2008 Units of Measure, Electronic
Unit of Measures Current Version CDER, CBER
Structured Product Medical Records, Identification of
(UCUM)
Labeling, Content Medicinal Products (IDMP)
of Labeling
FDA Structured Product Labeling- Units of Measure

Notes:

[1] For NDAs, ANDAs, and certain BLAs. See section II.A of the Providing Regulatory Submissions In Electronic Format — Standardized Study Data guidance document
[2] For certain INDs. See section II.A of the Providing Regulatory Submissions In Electronic Format - Standardized Study Data
[3] White House Consolidated Health Informatics Initiative. See Federal Register Notices.
[4] The WHO Drug Dictionary is named WHODrug Global
[5] Earlier versions (e.g., B2 Format) will not be supported by Uppsala Monitoring Centre after March 2019
[6] GENC- For all new systems and major systems redesign
[7] GENC - For all legacy systems
[8] " Ongoing"- Prior to the posting of a FDA Data Standards Catalog in 2011, FDA supported a number of data standards and there was no specific date when support began for some of these standards. As a result, the support status of “Ongoing” was entered for “Date Support Begins”.
[9] The simplified TS.xpt is a specific implementation of the CDISC SDTM standard being utilized by FDA (CDER and CBER) to establish the study start date or indicate that the study is exempted for evaluation by the Study Data Technical Rejection Criteria (TRC). For specifics on how to implement the simplified TS.xpt, please refer to the Study Data Technical Conformance Guide
[10] Please see the Study Data Technical Conformance Guide for clarification regarding when electronic standardized study data are required as part of a submission to address a public health emergency declared by the Secretary of Health and Human Services in accordance with section 319(a) of the Public Health Service Act (42 U.S.C. 247d(a)).
[11] Please see the Study Data Technical Conformance Guide for clarification regarding when electronic standardized study data are required for particular types of studies, such as pilot studies and failed studies submitted to ANDAs.
 Change History
Date Version
2011-06-13 1.0 Initial Release
2012-02-15 2.0 Added CDRH-supported data standards; added change history worksheet
Added support for SDTM v1.3/I.G. v3.1.3/define.xml 1.0; changed use of ASCII for the
2013-02-01 2.1
more generic "analysis program files"; Added support end date for SDTM IG 3.1.1

Added support for define.xml 2.0; added additional reference link for SNOMED CT and
2013-08-15 2.2 updated the "use" column; fixed links in reference column for Pharmacological class
terminology; updated link in reference column for Adverse Events Terminology.

2013-08-22 2.2 Added support for SDTM v2.1.2 Amendment 1.

Added "Instructions" worksheet; created new worksheet, "Terminology Standards", and
moved all terminology rows to this worksheet; renamed "Catalog" worksheet to "Data
Exchange Standards"; organized the Data Exchange Standards by use (e.g., regulatory
2014-01-17 3.0 electronic submission, clinical study datasets); added "Date Requirement Begins" and
"Date Requirement Ends" columns to the Data Exchange Standards and Terminology
worksheets; added new rows to the Data Exchange Standards worksheet: PDF 1.7, eCTD
v2
Addressed correction to Data Exchange Standards worksheet, eCTD Standard, Supported
2014-09-17 3.1
Version changed from "2" to "3.2.2".

Expanded support for SRS/UNII and NDF-RT.

Updated "Instructions" worksheet to clarify "supported version" description; also added
instructions for the terminology standards when there is support for more than one
2014-12-10 4.0 terminology for a given type of regulatory information (e.g., medication). Updated
introductory statement on "data exchange standards" worksheet-added reference link to
guidance and included reference to upcoming development, test, adoption catalog;
removed subheadings. Simplified reference link titles.

Instructions:
· Edited text in the Instructions tab for the Date Support Ends item.
Data Exchange Standards:
· Added dates to the Date Requirement Begins column for appropriate data exchange
standards
· Edited Postmarketing Safety Reporting- Adverse Events for Animal Drugs (ICSR) to
correct Data Exchange Standard and SDO columns.
· Edits Postmarketing Safety Reporting - Adverse Events for Drugs and Biologics (ICSR) to
correct Data Exchange Standard and Supported Version columns.
2015-04-09 4.1
· Added new row for Postmarketing Safety Reporting- Adverse Events for Vaccines
· Added new row for Postmarketing Safety Reporting- Lot Distribution Reports
· Separated CDER and CBER PDF Data Exchange Standards rows from other Centers
· Corrected Data Exchange Standards, Standard for Exchange of Nonclinical Data (SEND)
Implementation Guide Version from "3.1.2" to "3.0".
· Added values to the Date Requirement Begins columns on the Data Exchange Standards
Terminology Standards:
· Added dates to the Date Requirement Begins column for appropriate terminologies
· Add 1 row: Terminology (Medication) Who Drug Dictionary

Terminology Standards:
2015-04-29 4.2
· Add 1 row: Terminology (Laboratory Test) LOINC
Data Exchange Standards:
2015-05-27 4.3 - Added dates to Date Requirement Begins column for Electronic Common Technical
Document (eCTD) standard
 Change History
Date Version
Data Exchange Standards:
- Added new row for SDTM v1.4 & IG v3.2 support
2015-08-17 4.4
Terminology Standards:
-Added requirement date for LOINC

Data Exchange Standards:

- Added SPL for Post market Reporting – Submission to Global UDI Database (GUDID)
- Added Date Requirement Ends for CDISC Define.xml v1.0
- Updated text in Use column for XML Data Exchange Standard from
"SDTM, SEND, and ADaM define.xml file" to "Sharing Structured Information"
- Updated text in Use column for XML Data Exchange Standard from
2016-07-18 4.5 "Clinical study data definition" to "Study data definition"

Terminology Standards:
- Updated FDA Centers That Use This Terminology column to reflect CBER
implementation
- Added row for CDISC Terminology for Non Clinical Data Terminology Type
CDISC

Updated 4.5 Change History to reflect actual changes made:

- Removed first instance of “Terminology Standards"
- Correct CDISC spelling Typo
- Reflected what was changed in the Use column for XML Data Exchange Standard:
2016-08-31 4.5.1
Data Exchange Standards:
- Corrected the Define XML 1.0 Date Support Ends from "03/17/2017" to "03/15/2018" to
align with FRN.

Data Exchange Standards:

- Updated footnote 5 and 6 to reflect Date Requirement Begins for Master Files
-Removed placeholder for TA Standards as TA Standards have been placed in Technical
2017-04-13 4.5.2 Conformance Guide

Terminology Standards:
- Updated Maintenance Organization for WHO Drug Dictionary

Data Exchange Standards:

- Updated SEND IG v3.0 Date Support Ends and Date Requirement Ends to 3/15/2020
2017-8-21 4.6 - Added new row for SEND version 1.5, IG v3.1 with the Date Support Begins and Date
Requirement Begins
 Change History
Date Version

Data Exchange Standards:

- Updated SDTM v1.2 IG v3.1.2, IG v3.1.2 Amendment 1.2 Date Support Ends to
3/15/2019 for ANDA, NDA & certain BLAs. For INDs Date Support Ends to 3/15/2020.
- Corrected the SEND IG v3.0 Date Support Ends and Date Requirement Ends to
3/15/2019 for ANDA, NDA & certain BLAs. The Date Support Ends and Date Requirment
Ends to 3/15/2020 for INDs.
2017-09-01 4.7
Terminology Standards:
- Updated MedDRA Date Support Ends and Date Requirement Ends to 3/15/2020, as well
as updated the version to 8 or earlier
- Added new row for current version of MedDRA, with the Date Support Begins and Date
Requirement Begins

Data Exchange Standards:

- Updated ADaM version 2.1, IG v 1.0 Date Support Ends to 3/15/2018 for ANDA, NDA &
certain BLAs. The Date Support Ends to 3/15/2019 for INDs.
2017-10-02 4.8
- Added new row for ADaM version 2.1, IG v 1.1, with the Date Support Begins and Date
Requirement Begins

Data Exchange Standards:

2017-10-04 4.8.1 - Corrected ADaM version 2.1, IG v1.0 Date Support Ends to 3/15/2019 for ANDA, NDA &
certain BLAs. Corrected the Date Support Ends to 3/15/2020 for INDs.

Data Exchange Standards:

2017-10-13 4.8.2 -Added dates to Date Requirement Ends for SDTM IG 3.1.2, SDTM IG 3.1.2 Amendment
1, ADaM IG 1.0 and Define IG 1.0

Terminology Standards:
- Updated LOINC Date Support Begins to 10/20/2017
2017-10-20 4.9
- Extended LOINC Date Requirement Begins for ANDA, NDA, certain BLAs & certain INDs

Terminology Standards:
- Added footnote 4 and 5
- Updated WHO Drug Dictionary Date Support Ends and Date Requirement Ends
2017-10-24 4.10 - Updated WHO Drug Dictionary version to Not Specified
- Added new row for WHODrug Global B3 Format Annual with the Date Support Begins
and Date Requirement Begins
- Added Footnote 4 & 5
 Change History
Date Version
Intro & Definition of Terms:
- Renamed tab to Instr. and Column Descriptions
- Updated language in the instructions for use
- Updated the title of the Columns and Description sections
- Clarified the Description of each Catalog Term
Data
Exchange Standards: - Added
Statutory, Regulatory, or Guidance Authority column and links
- "Use" column is now the first column
- Updated the links within the Information Sources column -
Added new row for SPL image
- Added footnote #7

2018-04-20 5.0

Terminology Standards:
- Renamed Terminology Type to "Use"
- "Use" column is now the first column
- Renamed column FDA Centers That Use This Terminology to FDA Center(s)
- Added Statutory,
Regulatory, or Guidance Authority column and links
- Removed IHTSDO
- Added Technical Conformance Guide (TCG) to each cell that contained
Standarized Study Data under information sources column
- Added CFSAN as one of the centers that requires UNII
- Added new row for ICSR
- Added new row for SPL
- Removed original Information Source column and added a new Information Source
column to include TCG
Terminology Standards:
2018-08-02 5.1 - Name change from National Drug File- Reference Terminology to Medication Reference
Terminology (Med-RT) in March 2018

Terminology Standards:
- Updated MED-RT information sources
2018-12-19 5.2
- Updated all Study Data Technical Conformance Guide that has a new link
- Updated example of use for SNOMED CT

Data Exchange Standards:

- Updated SDTM IG v3.1.2 Amendement 1.0, ADaM IG v1.0, Define v1.0 with a date for
Requirement Ends
- Footnote 8 added
2019-07-19 6.0
Terminology Standards:
- GENC terminology standard added to the catalog
- Footnote 8 added

Terminology Standards:
2019-09-09 6.1
- UCUM terminology standard added to the catalog

Data Exchange Standards:

2020-04-10 6.2 - Added new row for SDTM version 1.8, SENDIG-AR v1.0 with the Date Support Begins
and Date Requirement Begins
 Change History
Date Version
Data Exchange Standards:
- Updated SDTM IG 3.1.3 with Date Support End and Date Requirement End
- Added new row for version 1.7 SDTM IG 3.3 with Date Support Begins and Date
2020-07-07 6.3 Requiremnet Begins
- Added new row for Define-XML v2.1 with Date Support Begins and Date Requirement
Begins

Data Exchange Standards:

- Added new row for CBER with Date Support Begins and Date Requirement Begins for
2020-07-15 6.4
version 1.5 SENDIG 3.1

Data Exchange Standards:

- Updated the Date Requirement Begins for version 1.7 SDTM IG 3.3
2020-07-17 6.5
- Updated the Date Requirement Begins for Define-XML v2.1
- Updated the Date Reuquirement End for SDTM IG 3.1.3
Data Exchange Standards:
2020-07-29 6.6
- New row added for current version of BioCompute with a Date Support Begins

Data Exchange Standards:

- Added new row for SEND version 1.6, SENDIG-DART v1.1 with the Date Support Begins
and Date Requirement Begins
2021-03-15 7.0 - Footnote 9 added

Terminology Standards:
- Footnote 9 added

Data Exchange Standards:

- Footnote 10 added
2021-06-22 7.1
Terminology Standards:
- Footnote 10 added
Data Exchange Standard:
2021-07-01 7.2
- Updated the Date Requirement Begins for SDTM version 1.8, SENDIG-AR v1.0
Data Exchange Standards:
- Footnote 11 added
2021-09-14 7.3
Terminology Standards:
- Footnote 11 added