Links

Additional Tool Links

The following tools are useful to know, not all are open source.

Tool	Type	Link
CDISC Dataset Generator (+ more)	Test Data, TLF Shells, CRFs, Specs, Protocol	https://cdiscdataset.com/
PhUSE CDISC Pilot Data + updated	Data	https://github.com/phuse-org/phuse-scripts/tree/master/data/adam/TDF_ADaM_v1.0 https://github.com/phuse-org/phuse-scripts/tree/master/data/sdtm/TDF_SDTM_v1.0
SEND Data Factory	Data, Programs	https://github.com/phuse-org/phuse-scripts/tree/master/contributed/Nonclinical/R/SEND%20Data%20Factory
MySEND (also for ADAM & SDTM)	Free Tool - No Open Source	http://info.pointcrosslifesciences.com/mysend
CLI Define.xml Tools	Tool	https://github.com/defineEditor/definetools
SAS Support Pages Macros	Macros	https://go.documentation.sas.com/?cdcId=pgmsascdc&cdcVersion=9.4_3.4&docsetId=pgmsashome&docsetTarget=home.htm
Can R be used for submissions?	Knowledge	https://www.slideshare.net/AdrianOlszewski1/gnu-r-in-clinical-research-and-evidencebased-medicine
A3 Community MDR - Browse CDISC CTs	Free Tool - No Open Source	https://www.s-cubed-global.com/news/a3-community-mdr-now-launched

Other Links

The following links might be useful for additional information.

Type	Link	Description
OS General	CDISC COSA	The CDISC Open Source Alliance Homepage (COSA)
	Open source Guide	Various guides about open source topics in general
	The Legal Side of Open Source	A legal overview
	Choose a license	Overview of Open Source Licenses
	Wikipedia - Business Concepts of Open Source	Overview about various business concepts for open source projects
Podcast	Verisian Community Podcast	Interviews and discussions with experts in clinical trials for clinical reporting, submission and review
	Where Technology Meets Science	Interviews and discussions focused on how technology can accelerate data science processes, particularly within life sciences and biopharmaceutical companies.
	Transformation in Trials	Interviews and discussions about transformation in clinical trials (broad range)
	Biostatistics Podcast (till 2024)	A podcast exploring biostatistics through expert insights, real-world applications, and interdisciplinary discussions.
R	pharmaverse.org	Pharma stack of open source R packages to enable clinical reporting
	R sassy	Package collection for R designed for SAS programmers
	R Validation Hub	R Validation Hub is a collaboration to support the adoption of R within a biopharmaceutical regulatory setting
	The Epidemiologist R Handbook	Excellent source for R evaluations
	openpharma.github.io	R Package overview related to pharma
	R Submissions Working Group	Homepage of the R Submissions Working Group
Other	PHUSE Open Data Repository	Interface to available pharma datasets (PODR is provided to PHUSE members for non-commercial use only)