Data Analysis
ADaM
MODEL: Analysis Data Model Version 2.1
IG: Analysis Data Model Data Structure for Adverse Event Analysis Version 1.0
IG: ADaM Implementation Guide for Medical Devices v1.0 (ADaMIG-MD)
IG: Analysis Data Model Implementation Guide for Non-compartmental Analysis
IG: ADaM Structure for Occurrence Data (OCCDS) Version 1.0
IG: ADaM Structure for Occurrence Data (OCCDS) Version 1.1
IG: Basic Data Structure for Population Pharmacokinetic (popPK) Analysis
IG: ADaM Basic Data Structure for Time-to-Event Analyses Version 1.0
IG: Analysis Data Model Implementation Guide Version 1.0
IG: Analysis Data Model Implementation Guide Version 1.1
IG: Analysis Data Model Implementation Guide Version 1.2
IG: Analysis Data Model Implementation Guide Version 1.3
CDISC Library Product Group: Product Group Data Analysis
Data Collection
CDASH
MODEL: Clinical Data Acquisition Standards Harmonization Model Version 1.0
MODEL: Clinical Data Acquisition Standards Harmonization Model Version 1.1
MODEL: Clinical Data Acquisition Standards Harmonization Model Version 1.2
MODEL: Clinical Data Acquisition Standards Harmonization Model Version 1.3
CDASHIG
IG: Clinical Data Acquisition Standards Harmonization (CDASH) User Guide V1.1
IG: Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.0
IG: Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.1
IG: Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.2
IG: Clinical Data Acquisition Standards Harmonization Implementation Guide for Human Clinical Trials Version 2.3
CDISC Library Product Group: Product Group Data Collection
Data Tabulation
SDTM
MODEL: Study Data Tabulation Model Version 1.2
MODEL: Study Data Tabulation Model Version 1.3
MODEL: Study Data Tabulation Model Version 1.4
MODEL: Study Data Tabulation Model Version 1.5
MODEL: Study Data Tabulation Model Version 1.6
MODEL: Study Data Tabulation Model Version 1.7
MODEL: Study Data Tabulation Model Version 1.8 (Final)
MODEL: Study Data Tabulation Model Version 2.0
SDTMIG
IG: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.1.2 (Final)
IG: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.1.3 (Final)
IG: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.2 (Final)
IG: Study Data Tabulation Model Implementation Guide: Human Clinical Trials Version 3.3 (Final)
IG: Study Data Tabulation Model Implementation Guide: Human Clinical Trials
IG: Study Data Tabulation Model Implementation Guide: Associated Persons Version 1.0 (Final)
IG: SDTM Implementation Guide for Medical Devices SDTMIG-MD 1.0 (Provisional)
IG: Study Data Tabulation Model Implementation Guide for Medical Devices (SDTMIG-MD) Version 1.1
CDISC Library Product Group: Product Group Data Tabulation
SENDIG
IG: Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies Version 3.0 (Final)
IG: Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies Version 3.1.1 (Final)
IG: Standard for Exchange of Nonclinical Data Implementation Guide: Nonclinical Studies Version 3.1 (Final)
IG: Standard for Exchange of Nonclinical Data Implementation Guide: Animal Rule Version 1.0 (Final)
IG: Standard for Exchange of Nonclinical Data Implementation Guide: Developmental and Reproductive Toxicology Version 1.1
QRS
instruments
QRS Instrument: Abnormal Involuntary Movement Scale Supplement v2.0
QRS Instrument: Acute Physiology and Chronic Health Evaluation II Supplement v1.0
QRS Instrument: Age, treatment with systemic antibiotics, leukocyte count, serum albumin, and serum creatinine as a measure of renal function Supplement v1.0
QRS Instrument: Clinical Global Impression Supplement v2.1
QRS Instrument: Hamilton Anxiety Rating Scale Supplement v2.1
QRS Instrument: Kurtzke Functional Systems Scores Supplement v2.0
QRS Instrument: Karnofsky Performance Scale Supplement v2.0
QRS Instrument: Patient Global Impression Supplement v1.1
QRS Instrument: 6 Minute Walk Test Supplement v1.0
CDISC Library Product Group: Product Group QRS Instrument
self
CDISC Library Product List: CDISC Library Product List
Terminology
packages
Terminology: ADaM Controlled Terminology Package 19 Effective 2014-09-26
Terminology: ADaM Controlled Terminology Package 24 Effective 2015-12-18
Terminology: ADaM Controlled Terminology Package 25 Effective 2016-03-25
Terminology: ADaM Controlled Terminology Package 27 Effective 2016-09-30
Terminology: ADaM Controlled Terminology Package 28 Effective 2016-12-16
Terminology: ADaM Controlled Terminology Package 29 Effective 2017-03-31
Terminology: ADaM Controlled Terminology Package 31 Effective 2017-09-29
Terminology: ADaM Controlled Terminology Package 36 Effective 2018-12-21
Terminology: ADaM Controlled Terminology Package 37 Effective 2019-03-29
Terminology: ADaM Controlled Terminology Package 40 Effective 2019-12-20
Terminology: ADaM Controlled Terminology Package 41 Effective 2020-03-27
Terminology: ADaM Controlled Terminology Package 42 Effective 2020-06-26
Terminology: ADaM Controlled Terminology Package 43 Effective 2020-11-06
Terminology: ADaM Controlled Terminology Package 48 Effective 2021-12-17
Terminology: ADaM Controlled Terminology Package 50 Effective 2022-06-24
Terminology: ADaM Controlled Terminology Package 53 Effective 2023-03-31
Terminology: ADaM Controlled Terminology Package 54 Effective 2023-06-30
Terminology: ADaM Controlled Terminology Package 57 Effective 2024-03-29
Terminology: CDASH Controlled Terminology Package 19 Effective 2014-09-26
Terminology: CDASH Controlled Terminology Package 21 Effective 2015-03-27
Terminology: CDASH Controlled Terminology Package 25 Effective 2016-03-25
Terminology: CDASH Controlled Terminology Package 27 Effective 2016-09-30
Terminology: CDASH Controlled Terminology Package 28 Effective 2016-12-16
Terminology: CDASH Controlled Terminology Package 31 Effective 2017-09-29
Terminology: CDASH Controlled Terminology Package 33 Effective 2018-03-30
Terminology: CDASH Controlled Terminology Package 34 Effective 2018-06-29
Terminology: CDASH Controlled Terminology Package 35 Effective 2018-09-28
Terminology: CDASH Controlled Terminology Package 36 Effective 2018-12-21
Terminology: CDASH Controlled Terminology Package 37 Effective 2019-03-29
Terminology: CDASH Controlled Terminology Package 38 Effective 2019-06-28
Terminology: CDASH Controlled Terminology Package 40 Effective 2019-12-20
Terminology: CDASH Controlled Terminology Package 43 Effective 2020-11-06
Terminology: CDASH Controlled Terminology Package 44 Effective 2020-12-18
Terminology: CDASH Controlled Terminology Package 45 Effective 2021-03-26
Terminology: CDASH Controlled Terminology Package 46 Effective 2021-06-25
Terminology: CDASH Controlled Terminology Package 47 Effective 2021-09-24
Terminology: CDASH Controlled Terminology Package 48 Effective 2021-12-17
Terminology: CDASH Controlled Terminology Package 50 Effective 2022-06-24
Terminology: CDASH Controlled Terminology Package 51 Effective 2022-09-30
Terminology: CDASH Controlled Terminology Package 52 Effective 2022-12-16
Terminology: COA Controlled Terminology Package 20 Effective 2014-12-19
Terminology: COA Controlled Terminology Package 21 Effective 2015-03-27
Terminology: DDF Controlled Terminology Package 51 Effective 2022-09-30
Terminology: DDF Controlled Terminology Package 52 Effective 2022-12-16
Terminology: DDF Controlled Terminology Package 53 Effective 2023-03-31
Terminology: DDF Controlled Terminology Package 54 Effective 2023-06-30
Terminology: DDF Controlled Terminology Package 55 Effective 2023-09-29
Terminology: DDF Controlled Terminology Package 56 Effective 2023-12-15
Terminology: DDF Controlled Terminology Package 57 Effective 2024-03-29
Terminology: DEFINE-XML Controlled Terminology Package 40 Effective 2019-12-20
Terminology: DEFINE-XML Controlled Terminology Package 41 Effective 2020-03-27
Terminology: DEFINE-XML Controlled Terminology Package 42 Effective 2020-06-26
Terminology: DEFINE-XML Controlled Terminology Package 43 Effective 2020-11-06
Terminology: DEFINE-XML Controlled Terminology Package 44 Effective 2020-12-18
Terminology: Define-XML Controlled Terminology Package 45 Effective 2021-03-26
Terminology: Define-XML Controlled Terminology Package 46 Effective 2021-06-25
Terminology: Define-XML Controlled Terminology Package 47 Effective 2021-09-24
Terminology: Define-XML Controlled Terminology Package 48 Effective 2021-12-17
Terminology: Define-XML Controlled Terminology Package 51 Effective 2022-09-30
Terminology: Define-XML Controlled Terminology Package 52 Effective 2022-12-16
Terminology: Define-XML Controlled Terminology Package 54 Effective 2023-06-30
Terminology: Define-XML Controlled Terminology Package 56 Effective 2023-12-15
Terminology: Define-XML Controlled Terminology Package 57 Effective 2024-03-29
Terminology: GLOSSARY Controlled Terminology Package 44 Effective 2020-12-18
Terminology: Glossary Controlled Terminology Package 48 Effective 2021-12-17
Terminology: Glossary Controlled Terminology Package 52 Effective 2022-12-16
Terminology: Glossary Controlled Terminology Package 56 Effective 2023-12-15
Terminology: MRCT Controlled Terminology Package 57 Effective 2024-03-29
Terminology: PROTOCOL Controlled Terminology Package 29 Effective 2017-03-31
Terminology: PROTOCOL Controlled Terminology Package 30 Effective 2017-06-30
Terminology: PROTOCOL Controlled Terminology Package 31 Effective 2017-09-29
Terminology: PROTOCOL Controlled Terminology Package 33 Effective 2018-03-30
Terminology: PROTOCOL Controlled Terminology Package 34 Effective 2018-06-29
Terminology: PROTOCOL Controlled Terminology Package 35 Effective 2018-09-28
Terminology: PROTOCOL Controlled Terminology Package 37 Effective 2019-03-29
Terminology: PROTOCOL Controlled Terminology Package 38 Effective 2019-06-28
Terminology: PROTOCOL Controlled Terminology Package 39 Effective 2019-09-27
Terminology: PROTOCOL Controlled Terminology Package 40 Effective 2019-12-20
Terminology: PROTOCOL Controlled Terminology Package 41 Effective 2020-03-27
Terminology: PROTOCOL Controlled Terminology Package 42 Effective 2020-06-26
Terminology: PROTOCOL Controlled Terminology Package 43 Effective 2020-11-06
Terminology: PROTOCOL Controlled Terminology Package 44 Effective 2020-12-18
Terminology: Protocol Controlled Terminology Package 45 Effective 2021-03-26
Terminology: Protocol Controlled Terminology Package 46 Effective 2021-06-25
Terminology: Protocol Controlled Terminology Package 47 Effective 2021-09-24
Terminology: Protocol Controlled Terminology Package 48 Effective 2021-12-17
Terminology: Protocol Controlled Terminology Package 49 Effective 2022-03-25
Terminology: Protocol Controlled Terminology Package 50 Effective 2022-06-24
Terminology: Protocol Controlled Terminology Package 51 Effective 2022-09-30
Terminology: Protocol Controlled Terminology Package 52 Effective 2022-12-16
Terminology: Protocol Controlled Terminology Package 53 Effective 2023-03-31
Terminology: Protocol Controlled Terminology Package 54 Effective 2023-06-30
Terminology: Protocol Controlled Terminology Package 55 Effective 2023-09-29
Terminology: Protocol Controlled Terminology Package 56 Effective 2023-12-15
Terminology: Protocol Controlled Terminology Package 57 Effective 2024-03-29
Terminology: QRS Controlled Terminology Package 22 Effective 2015-06-26
Terminology: QRS Controlled Terminology Package 23 Effective 2015-09-25
Terminology: QS-FT Controlled Terminology Package 19 Effective 2014-09-26
Terminology: SDTM Controlled Terminology Package 19 Effective 2014-09-26
Terminology: SDTM Controlled Terminology Package 20 Effective 2014-12-19
Terminology: SDTM Controlled Terminology Package 21 Effective 2015-03-27
Terminology: SDTM Controlled Terminology Package 22 Effective 2015-06-26
Terminology: SDTM Controlled Terminology Package 23 Effective 2015-09-25
Terminology: SDTM Controlled Terminology Package 24 Effective 2015-12-18
Terminology: SDTM Controlled Terminology Package 25 Effective 2016-03-25
Terminology: SDTM Controlled Terminology Package 26 Effective 2016-06-24
Terminology: SDTM Controlled Terminology Package 27 Effective 2016-09-30
Terminology: SDTM Controlled Terminology Package 28 Effective 2016-12-16
Terminology: SDTM Controlled Terminology Package 29 Effective 2017-03-31
Terminology: SDTM Controlled Terminology Package 30 Effective 2017-06-30
Terminology: SDTM Controlled Terminology Package 31 Effective 2017-09-29
Terminology: SDTM Controlled Terminology Package 32 Effective 2017-12-22
Terminology: SDTM Controlled Terminology Package 33 Effective 2018-03-30
Terminology: SDTM Controlled Terminology Package 34 Effective 2018-06-29
Terminology: SDTM Controlled Terminology Package 35 Effective 2018-09-28
Terminology: SDTM Controlled Terminology Package 36 Effective 2018-12-21
Terminology: SDTM Controlled Terminology Package 37 Effective 2019-03-29
Terminology: SDTM Controlled Terminology Package 38 Effective 2019-06-28
Terminology: SDTM Controlled Terminology Package 39 Effective 2019-09-27
Terminology: SDTM Controlled Terminology Package 40 Effective 2019-12-20
Terminology: SDTM Controlled Terminology Package 41 Effective 2020-03-27
Terminology: SDTM Controlled Terminology Package 42 Effective 2020-06-26
Terminology: SDTM Controlled Terminology Package 43 Effective 2020-11-06
Terminology: SDTM Controlled Terminology Package 44 Effective 2020-12-18
Terminology: SDTM Controlled Terminology Package 45 Effective 2021-03-26
Terminology: SDTM Controlled Terminology Package 46 Effective 2021-06-25
Terminology: SDTM Controlled Terminology Package 47 Effective 2021-09-24
Terminology: SDTM Controlled Terminology Package 48 Effective 2021-12-17
Terminology: SDTM Controlled Terminology Package 49 Effective 2022-03-25
Terminology: SDTM Controlled Terminology Package 50 Effective 2022-06-24
Terminology: SDTM Controlled Terminology Package 51 Effective 2022-09-30
Terminology: SDTM Controlled Terminology Package 52 Effective 2022-12-16
Terminology: SDTM Controlled Terminology Package 53 Effective 2023-03-31
Terminology: SDTM Controlled Terminology Package 54 Effective 2023-06-30
Terminology: SDTM Controlled Terminology Package 55 Effective 2023-09-29
Terminology: SDTM Controlled Terminology Package 56 Effective 2023-12-15
Terminology: SDTM Controlled Terminology Package 57 Effective 2024-03-29
Terminology: SEND Controlled Terminology Package 19 Effective 2014-09-26
Terminology: SEND Controlled Terminology Package 20 Effective 2014-12-19
Terminology: SEND Controlled Terminology Package 21 Effective 2015-03-27
Terminology: SEND Controlled Terminology Package 22 Effective 2015-06-26
Terminology: SEND Controlled Terminology Package 23 Effective 2015-09-25
Terminology: SEND Controlled Terminology Package 24 Effective 2015-12-18
Terminology: SEND Controlled Terminology Package 25 Effective 2016-03-25
Terminology: SEND Controlled Terminology Package 26 Effective 2016-06-24
Terminology: SEND Controlled Terminology Package 27 Effective 2016-09-30
Terminology: SEND Controlled Terminology Package 28 Effective 2016-12-16
Terminology: SEND Controlled Terminology Package 29 Effective 2017-03-31
Terminology: SEND Controlled Terminology Package 30 Effective 2017-06-30
Terminology: SEND Controlled Terminology Package 31 Effective 2017-09-29
Terminology: SEND Controlled Terminology Package 32 Effective 2017-12-22
Terminology: SEND Controlled Terminology Package 33 Effective 2018-03-30
Terminology: SEND Controlled Terminology Package 34 Effective 2018-06-29
Terminology: SEND Controlled Terminology Package 35 Effective 2018-09-28
Terminology: SEND Controlled Terminology Package 36 Effective 2018-12-21
Terminology: SEND Controlled Terminology Package 37 Effective 2019-03-29
Terminology: SEND Controlled Terminology Package 38 Effective 2019-06-28
Terminology: SEND Controlled Terminology Package 39 Effective 2019-09-27
Terminology: SEND Controlled Terminology Package 40 Effective 2019-12-20
Terminology: SEND Controlled Terminology Package 41 Effective 2020-03-27
Terminology: SEND Controlled Terminology Package 42 Effective 2020-06-26
Terminology: SEND Controlled Terminology Package 43 Effective 2020-11-06
Terminology: SEND Controlled Terminology Package 44 Effective 2020-12-18
Terminology: SEND Controlled Terminology Package 45 Effective 2021-03-26
Terminology: SEND Controlled Terminology Package 46 Effective 2021-06-25
Terminology: SEND Controlled Terminology Package 47 Effective 2021-09-24
Terminology: SEND Controlled Terminology Package 48 Effective 2021-12-17
Terminology: SEND Controlled Terminology Package 49 Effective 2022-03-25
Terminology: SEND Controlled Terminology Package 50 Effective 2022-06-24
Terminology: SEND Controlled Terminology Package 51 Effective 2022-09-30
Terminology: SEND Controlled Terminology Package 52 Effective 2022-12-16
Terminology: SEND Controlled Terminology Package 53 Effective 2023-03-31
Terminology: SEND Controlled Terminology Package 54 Effective 2023-06-30
Terminology: SEND Controlled Terminology Package 55 Effective 2023-09-29
Terminology: SEND Controlled Terminology Package 56 Effective 2023-12-15
Terminology: SEND Controlled Terminology Package 57 Effective 2024-03-29
CDISC Library Product Group: Product Group Terminology