CDISC Library Archives

CDISC Library Archives (formerly CDISC SHARE Exports) make CDISC standards accessible in a variety of electronic form and help users find, understand and use rich metadata and controlled terminologies relevant to clinical studies more efficiently and consistently, and improve integration and traceability of clinical data from protocol through analysis.

  • Metadata is the machine-readable content published from CDISC Library. Each format is a link that allows you to download a file containing the standards metadata.

  • Documents are published PDFs and include a standard’s specifications, implementation guides (IG), or user guides (UG).
  • Diff (Difference) files summarize all changes from one version of a standard to the next, including new, updated and deprecated/removed content.

A Diff file displays differences between two versioned standards. A data comparison program reads in metadata of two versions of a standard in the CDISC Library (e.g., SDTM v3.1.2 and SDTMIG v3.2), detects changes based on key elements (e.g., domain, variable) and outputs the type of changes (add, modify, drop), the attribute where a change occurs (e.g., label, datatype), and the new and old values. The Diff file's structure is one line per key per attribute per change.

CDASH

Date Posted to Archive Content Version Type Download Files
CDASH Model 1.1
2020-03-20 CDASH Model 1.1 Metadata

Excel

CDASHIG 2.1
2020-03-20 CDASH IG 2.1 Metadata

Excel

CDASH Model 1.0
2017-11-27 CDASH Model 1.0 Metadata Excel
CDASH 2.0
2017-11-27 CDASH IG 2.0 Metadata Excel
CDASH UG 1.1
2014-06-02 CDASH UG 1.1 Metadata ODM v1.3.2 | CSV | Excel
2014-06-02 CDASH UG + CT 1.1+2013-12 Bundle ODM | Excel
2014-06-02 CDASH 1.1 Document PDF
2014-06-02 CDASH UG 1.1 Document PDF
CDASH Terminology
2021-01-21 CDASH Terminology 2020-12 Metadata

ODM v1.3.1 | RDF | Excel Diff

2020-11-25 CDASH Terminology 2020-11 Metadata

ODM v1.3.1 | RDF | Excel Diff

2020-01-15 CDASH Terminology 2019-12 Metadata

ODM v1.3.1 | RDF | Excel Diff

2019-09-03 CDASH Terminology 2019-06 Metadata

ODM v1.3.1 | RDF | Excel Diff

2019-06-06 CDASH Terminology 2019-03 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-03-01 CDASH Terminology 2018-12 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-11-20 CDASH Terminology 2018-09 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-08-14 CDASH Terminology 2018-06 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08 CDASH Terminology 2017-09 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08 CDASH Terminology 2016-12 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08 CDASH Terminology 2016-09 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-05-26 CDASH Terminology 2016-03 Metadata

ODM v1.3.1 | RDF | Excel | Diff

2015-04-10 CDASH Terminology 2015-03 Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2014-10-17 CDASH Terminology 2014-09 Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17 CDASH Terminology 2014-03 Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-06-02 CDASH Terminology 2013-12 Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

CDASH To SDTM Map
2015-02-02 CDASH To SDTM Map 1.1 to 3.1.2 Metadata

Excel

SDTM

Date Posted to Archive Content Version Type Download Files
SDTM 1.8*

2020-03-20

SDTM

1.8

Metadata

Excel

2020-03-20

SDTM Diff

1.8 - 1.7

Metadata

Excel

SDTM 1.7

2018-11-19

SDTM

1.7

Metadata

Excel

2018-11-19

SDTM Diff

1.7 - 1.6

Metadata

Excel

SDTMIG 3.3

2018-11-19

SDTM IG

3.3

Metadata

Excel

2018-11-19

SDTM Diff

3.3 - 3.2

Metadata

Excel

2020-06-26

SDTM IG

3.3

Document

PDF

SDTM 1.6*

2017-12-20

SDTM

1.6

Metadata

Excel

2017-12-20

SDTM Diff

1.6 - 1.5

Metadata

Excel

SDTM 1.5*

2017-11-10

SDTM

1.5

Metadata

Excel

2017-11-10

SDTM Diff

1.5 - 1.4

Metadata

Excel

2016-08-22

SDTM

1.5

Document

PDF

SDTMIG PGx (IG 1.0)

2016-05-12

SDTM IG

1.0

Metadata

Excel

2016-05-12

SDTM IG

1.0

Document

PDF

SDTMIG Medical Devices 1.0

2014-11-20

SDTM IG

1.0

Metadata

Define-XML v2.0 | Define-XML v1.0 | Excel

2014-11-20

SDTM IG

1.0

Document

PDF

SDTM 1.4 (IG 3.2)

2015-02-02

SDTM IG Diff

3.2 - 3.1.3

Metadata

Excel

2014-08-21

SDTM IG

1.4 (3.2)

Metadata

Define-XML v2.0 | Define-XML v1.0 | Excel

2014-08-21

SDTM + CT

1.4+2013-12-20

Bundle

Define-XML v2.0 | Excel

2014-08-21

SDTM IG

1.3 (3.1.3)

Document Bundle

PDF

SDTM 1.3 (IG 3.1.3)

2014-08-21

SDTM IG

1.3 (3.1.3)

Metadata

Define-XML v2.0 | Define-XML v1.0 | Excel

2014-08-21

SDTM + CT

1.3+2013-12-20

Bundle

Define-XML v2.0 | Excel

2014-08-21

SDTM IG

1.3 (3.1.3)

Document Bundle

PDF

SDTM1.2 (IG 3.1.2)

2014-06-02

SDTM IG

1.2 (3.1.2)

Metadata

Define-XML v2.0 | Define-XML v1.0 | CSV | Excel

2014-06-02 SDTM + CT 1.2+2013-12 Bundle Define-XML v2.0 | Excel

2014-06-02

SDTM

1.2

Document

PDF

2014-06-02

SDTM IG

3.1.2

Document

PDF

SDTM Terminology

2021-01-21

SDTM Terminology

2020-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-11-25

SDTM Terminology

2020-11

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-09-09

SDTM Terminology

2020-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-05-05

SDTM Terminology

2020-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-01-15

SDTM Terminology

2019-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-12-20

SDTM Terminology

2019-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

SDTM Terminology

2019-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-06-06

SDTM Terminology

2019-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-03-01

SDTM Terminology

2018-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-11-20

SDTM Terminology

2018-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-08-14

SDTM Terminology

2018-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2017-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2017-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2017-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2017-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2016-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

SDTM Terminology

2016-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-07-5

SDTM Terminology

2016-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-05-26

SDTM Terminology

2016-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-02-12

SDTM Terminology

2015-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-01-02

SDTMIG 3.2 Variable to Codelist Mapping

N/A

Metadata

Excel

2015-12-07

SDTM Terminology

2015-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2015-12-07

QRS Terminology

2015-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2015-09-16

SDTM Terminology

2015-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2015-09-16

QRS Terminology

2015-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2015-04-10

SDTM Terminology

2015-03

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2015-04-10

COA Terminology

2015-03

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2015-04-10

SDTM Terminology

2014-12

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2015-04-10

COA Terminology

2014-12

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2014-10-17

SDTM Terminology

2014-09

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

QS FT Terminology

2014-09

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

SDTM Terminology

2014-06

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

QS FT Terminology

2014-06

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

SDTM Terminology

2014-03

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

QS Terminology

2014-03

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-06-02

SDTM Terminology

2013-12

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-06-02

QS Terminology

2013-12

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

SEND

Date Posted to Archive Content Version Type Download Files
SENDIG-AR 1.0

2020-03-20

SENDIG-AR

1.0

Metadata

Excel

SENDIG-DART 1.1

2017-12-20

SENDIG-DART

1.1

Metadata

Define-XML v2.0 | Excel

2017-12-20

SENDIG-DART Diff

1.1 - 1.0

Metadata

Excel

2017-12-20

SENDIG-DART

1.1

Document

PDF

SEND IG 3.1

2016-08-22

SEND IG

3.1

Metadata

Excel

2016-08-22

SEND IG Diff

3.1 - 3.0

Metadata

Excel

2016-08-22

SEND IG

3.1

Document

PDF

SEND IG 3.0

2014-10-17

SEND IG

3.0 Metadata

Excel

SEND Terminology

2021-01-21

SEND Terminology

2020-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2020-11-25

SEND Terminology

2020-11

Metadata

ODM v1.3.1 | RDF Excel | Diff

2020-09-09

SEND Terminology

2020-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2020-05-05

SEND Terminology

2020-03

Metadata

ODM v1.3.1 | RDF Excel | Diff

2020-01-15

SEND Terminology

2019-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2019-12-20

SEND Terminology

2019-09

Metadata

ODM v1.3.1 | RDF Excel | Diff

2019-09-03

SEND Terminology

2019-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2019-06-06

SEND Terminology

2019-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-03-01

SEND Terminology

2018-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-11-20

SEND Terminology

2018-09

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-08-14

SEND Terminology

2018-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2017-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2017-09

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2017-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2017-03

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2016-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2018-02-08

SEND Terminology

2016-09

Metadata

ODM v1.3.1 | RDF Excel | Diff

2016-07-05

SEND Terminology

2016-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2016-05-26

SEND Terminology

2016-03

Metadata

ODM v1.3.1 | RDF Excel | Diff

2016-02-12

SEND Terminology

2015-12

Metadata

ODM v1.3.1 | RDF Excel | Diff

2015-12-07

SEND Terminology

2015-09

Metadata

ODM v1.3.1 | RDF Excel | Diff

2015-09-22

SEND Terminology

2015-06

Metadata

ODM v1.3.1 | RDF Excel | Diff

2015-04-10

SEND Terminology

2015-03

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v2.0 | Diff

2015-04-10

SEND Terminology

2014-12

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v2.0 |Diff

2014-10-17

SEND Terminology

2014-09

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

SEND Terminology

2014-06

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-10-17

SEND Terminology

2014-03

Metadata

ODM v1.3.1 | RDF Excel | Define-XML v1.0 | Define-XML v2.0

2014-06-02

SEND Terminology

2013-12

Metadata

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

ADaM

Date Posted to Archive Content Version Type Download Files
ADaM 2.1
2020-03-20 ADaM IG 1.2 Metadata Excel | PDF

2017-04-03

ADaM IG

1.1

Metadata

Excel | PDF

2017-04-03

ADaM OCCDS

1.0

Metadata

Excel | PDF

2017-04-03

AE

1.0

Metadata

Excel | PDF

2017-04-03

ADaM IG

1.0

Metadata

Excel | PDF

ADaM Terminology

2020-11-25

ADaM Terminology

2020-11

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-09-09

ADaM Terminology

2020-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-05-05

ADaM Terminology

2020-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-01-15

ADaM Terminology

2019-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-06-06

ADaM Terminology

2019-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-03-01

ADaM Terminology

2018-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

ADaM Terminology

2017-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

ADaM Terminology

2017-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

ADaM Terminology

2016-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2018-02-08

ADaM Terminology

2016-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2016-05-26

ADaM Terminology

2016-03

Metadata

ODM v1.3.1 | RDF | Excel  | Diff

2016-02-12

ADaM Terminology

2015-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2014-10-17

ADaM Terminology

2014-09

Metadata 

ODM v1.3.1 | RDF | Excel | Define-XML v1.0 | Define-XML v2.0

2014-06-02

ADaM Terminology

2013-12

Metadata

ODM v1.3.1 | RDF | Excel |  Define-XML v1.0 | Define-XML v2.0

Protocol

Date Posted to Archive Content Version Type Download Files
Protocol Terminology

2021-01-21

Protocol Terminology

2020-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-11-25

Protocol Terminology

2020-11

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-09-09

Protocol Terminology

2020-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-05-05

Protocol Terminology

2020-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-01-15

Protocol Terminology

2019-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-12-20

Protocol Terminology

2019-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2019-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2019-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2018-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2018-06

Metadata

ODM v1.3.1 | RDF |  Excel | Diff

2019-09-03

Protocol Terminology

2018-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2017-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2017-09

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2017-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2019-09-03

Protocol Terminology

2017-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

CDISC Glossary

Date Posted to Archive Content Version Type Download Files
CDISC Glossary Terminology

2021-01-21

CDISC Glossary Terminology

2020-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

Define-XML

Date Posted to Archive Content Version Type Download Files
Define-XML Terminology

2021-01-21

Define-XML Terminology

2020-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-11-25

Define-XML Terminology

2020-11

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-09-09

Define-XML Terminology

2020-06

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-05-05

Define-XML Terminology

2020-03

Metadata

ODM v1.3.1 | RDF | Excel | Diff

2020-01-15

Define-XML Terminology

2019-12

Metadata

ODM v1.3.1 | RDF | Excel | Diff

Therapeutic Areas

Date Posted to Archive Content Version Type Download Files
TA Standards 

2015-12-23

LB BAR

Draft

Metadata

LB BRIDG Alignment Report

2015-12-23

QS BAR

Draft

Metadata

QS BRIDG Alignment Report

2015-04-28

Alzheimer's TA

1.0

Metadata

Alzheimer's TAUG Metadata

2015-04-28

Asthma TA

1.0 Metadata

Asthma TAUG Metadata

2015-05-05

Cardiovascular TA

1.0

Metadata

Cardiovascular TAUG Metadata

2015-05-05

Diabetes TA

1.0

Metadata

Diabetes TAUG Metadata

2015-09-10

Hepatitis C TA

1.0

Metadata

Hepatitis C TAUG Metadata

2015-06-08

Influenza TA

1.0

Metadata

Influenza TAUG Metadata

2015-06-08

Multiple Sclerosis TA

1.0

Metadata

Multiple Sclerosis TAUG Metadata

2015-07-31

QT Studies TA

1.0

Metadata

QT Studies TAUG Metadata

2015-04-28

Virology TA

1.0

Metadata

Virology TAUG Metadata