CDISC Open Source Alliance Quarterly Spotlight - Q2


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Join CDISC and Open-Source Developer for the COSA Quarterly Spotlight!

Register to hear from open-source developers in the CDISC community as they showcase their free tools as part of the CDISC Open Source Alliance (COSA). Join us to hear presentations on:

  • {sdtm.oak} v0.1 Release
  • CORE: Authoring & Running Your Own Rules
  • CORE: Checking USDM for Conformance

{sdtm.oak} v0.1 Release

Ganapathy

Rammprasad (Ram) Ganapathy from Roche/Genentech will present on an EDC and standards-agnostic solution that enables a modular approach to programming SDTM in R.

Ganapathy is a Principal Data Scientist at Roche/Genentech with over 15 years of experience in EDC and statistical programming.

He leads the OAK team and is also the product owner of OAK. He and his team developed R based SDTM automation solution OAK from proof of concept to full implementation, and now OAK is used for SDTM creation across all studies at Roche. Ram is also the Product Owner for the open-source {sdtm.oak}.


CORE: Authoring & Running Your Own Rules

RadelickiThe CORE project encourages the use of its open-source software to test study data for conformance to various standards by using the same set of unambiguous rules governed by CDISC. Next to these rules, establishing an industry-standard method for rule creation offers a promising prospect.

Roman Radelicki will explore creating custom rules using the Conformance Rule Authoring tool. Our journey/challenges of implementing the authoring tool and running custom rules with the CORE-engine, will be shared.

Radelicki started his career as Programmer in 2006 and joined SGS in 2009. During his career at SGS he held several positions and became Head Data Technology in 2021. He is mainly responsible for managing the data engineering, data programming and data science teams, providing support to the different departments. Roman is BSc in Computer Science and also in Multimedia Design.


CORE: Checking USDM for Conformance

Snoeijer DDF rule shave been developed based on the Unified Study Definition Model (USDM) requirements. Berber Snoeijer's presentation will cover the development of CORE DDF rules in the Proof of Concept phase which has been finalized, along with the plans for the next phase to align with version 3.0 and 4.0 of the USDM.

Snoeijer will also cover the corresponding required changes to the CORE engine and rule editor to enable checking of the API json file and specific USDM requirements. 

Snoeijer is the USDM development team lead at CDISC and was involved in the proof of concept phase for the CORE DDF rules. She has a background in biomedical sciences and programming and more than 25 years of experience in the industry in data analysis, data flow optimization, and software development. 


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