Open Forum: Regulatory Acceptance of Open-Source Submissions

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Last updated: Sept 24, 2024 by Alex Pearce
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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. 

PresenterBio

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.