Open Source – Regulatory Acceptance of Open-Source Submissions
The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting. Questions we addressed during this Webinar: Will the FDA accept data and analyses generated with solutions developed and available as open source? Will other regulatory agencies accept data and analyses generated with solutions developed and available as open source? As well as the GitHub Discussion, we are hosting a series of forums throughout the year. See the Working Group Events page for further details.

Open Source – Regulatory Acceptance of Open-Source Submissions

The Open Source Technology in Clinical Data Analysis (OSTCDA) project was set up with the aim to create a manuscript on the integration of open-source software solutions for clinical data management, analysis and reporting.

Questions we addressed during this Webinar:

Will the FDA accept data and analyses generated with solutions developed and available as open source?
Will other regulatory agencies accept data and analyses generated with solutions developed and available as open source?

As well as the GitHub Discussion, we are hosting a series of forums throughout the year. See the Working Group Events page for further details.

Presenter	Bio
	Katja Glaß, Katja Glass Consulting As a part-time open-source consultant, Katja Glaß hosts a portal about open-source solutions for pharma (www.glacon.eu/portal) and provides open-source consulting. Her key experience is in SAS, web technologies, ADaM, Define-XML and TFL. Katja is a COSA Board member and a very active member of PHUSE. Additionally, she is the community manager for the OpenStudyBuilder open-source project.

Presenter

Bio

Katja Glaß, Katja Glass Consulting

As a part-time open-source consultant, Katja Glaß hosts a portal about open-source solutions for pharma (www.glacon.eu/portal) and provides open-source consulting. Her key experience is in SAS, web technologies, ADaM, Define-XML and TFL. Katja is a COSA Board member and a very active member of PHUSE. Additionally, she is the community manager for the OpenStudyBuilder open-source project.