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
- 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 |
| Name | Link |
|---|---|
| SDTM Terminology | xls pdf |
| CDISC Glossary |
- CDISC and PhUSE MOU http://www.phusewiki.org/wiki/images/6/67/PhUSE_CDISC_MOU_2018_to_2019.pdf
define.xml
- 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
- 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
- CDISC CDASH Model 1.0 and CDASH Implementation Guide 2.0 : Open for PUBLIC COMMENT through 16 August 2016
- 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
- FDA Standaridzed Study Data 2014-12 https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM292334.pdf
- MedDRA version 19.0 https://tools.meddra.org/wbb
- ATC Code Version 2017 https://www.whocc.no/atc_ddd_index/
- oxygen xml edisor
https://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources