asancpt / CDISC

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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	pdf

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

• https://www.comodo.com/home/email-security/free-email-certificate.php

Softwares

• oxygen xml edisor

dataset-xml

https://wiki.cdisc.org/display/PUB/CDISC+Dataset-XML+Resources