Introduction: CDISC
There are tons of materials regarding CDISC. I just want to keep the essential materials in a simple and neat way.
SDTM is one of the required standards that sponsors must use as specified in the FDA’s Data Standards Catalog (see section II.C) for NDA, ANDA, and certain BLA submissions effective December 2016.
Reference: https://hvtnews.files.wordpress.com/2013/10/5-6-originalsize.jpg?w=595&h=347
Wikis
- CDISC wiki https://wiki.cdisc.org/
- PhUSE wiki http://www.phusewiki.org/
Current Version (as of 2020-08-12
)
Name | Version | Link |
---|---|---|
SDTM | v1.8 | https://www.cdisc.org/standards/foundational/sdtm/sdtm-v1-8 |
SDTMIG | v3.3 | https://www.cdisc.org/standards/foundational/sdtmig/sdtmig-v3-3 |
Downloads
Name | Link |
---|---|
SDTM Terminology | xls pdf |
CDISC Glossary |
News
- CDISC and PhUSE MOU http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf
Required files
define.xml
SDTM
SDTM Implementation Guide
- CDISC SDTM Implementation Guide 3.2 <www.cdisc.org/system/files/members/standard/foundational/sdtmig/sdtmig_20v3.2_20noportfolio.pdf>
- CDISC SDTM Implementation Guide 3.1.2 - no login required. http://meta-x.com/cdisc/doc/SDTM%20Implementation%20Guide%20V3.1.2.pdf
SDTM Terminology
- CDISC Terminology https://www.cancer.gov/research/resources/terminology/cdisc
- [CDISC SDTM Terminology.xls 2016-12-16](SDTM Terminology.xls) / http://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.xls
- [CDISC SDTM Terminology.pdf 2016-12-16](SDTM Terminology.pdf) / http://evs.nci.nih.gov/ftp1/CDISC/SDTM/SDTM%20Terminology.pdf
CDASH IG v2.0 & Model v1.0
- CDISC CDASH Model 1.0 and CDASH Implementation Guide 2.0 : Open for PUBLIC COMMENT through 16 August 2016
R Packages
- CDISCQuery | a Shiny web application to search CDISC terminologies using SPARQL.
- R4DSXML | R4DSXML is R package for import CDISC Dataset-XML and Define-XML as R data frame.
- phuse | R package
Data Management of Clinical Trials
FDA
- FDA Standaridzed Study Data 2014-12 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf
Medical Dictionary
- MedDRA version 19.0 https://tools.meddra.org/wbb
- ATC Code Version 2017 https://www.whocc.no/atc_ddd_index/
COMODO
Softwares
- oxygen xml edisor
dataset-xml
https://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources