Clinical-Trial-Reference-Documents

This folder contains publicly available reference documentation for Clinical Trials

PhUSE

https://phuse.global

PhUSE Good Programming Practice - Guidnace for individuals, teams, and orginization

https://advance.phuse.global/display/WEL/Good+Programming+Practice+Guidance

CDISC CDASH

https://www.cdisc.org/standards/foundational/cdash

CDISC CDASH Slides by Gowthami Saripalli: https://www.slideshare.net/Gowthami6789/cdash-gs?from_search=2

CDISC SDTM

https://www.cdisc.org/standards/foundational/sdtm

IS04: An Introduction to SDTM – 298 pages in 20 minutes?! by Jennie Mc Guirk https://www.lexjansen.com/phuse/2012/is/IS04_ppt.pdf

CDISC ADaM

https://www.cdisc.org/standards/foundational/adam

Study Data Technical Conformance Guide - Technical Specifications Document

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/study-data-technical-conformance-guide-technical-specifications-document

Codelists

https://ncit.nci.nih.gov/ncitbrowser/pages/multiple_search.jsf?nav_type=terminologies

UNII https://evs.nci.nih.gov/ftp1/FDA/UNII/

Med-RT https://evs.nci.nih.gov/ftp1/MED-RT/

NCI (National Cancer Institute) Researcher Resources

https://www.cancer.gov/research/resources?app_module_route=/&&app_module_id=cgov_r4r_app

Implementation of Data Cut Off in Analysis of Clinical Trials

https://www.lexjansen.com/pharmasug/2018/DS/PharmaSUG-2018-DS19.pdf

Submission Standards - To be added