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Clinical Trials Working Group

Objective: To allow adequate representation of clinical trial data in OMOP.

First use case: To convert clinical trial data in CDISC SDTM format to OMOP, with a view to allowing trial planning optimization.

Approach: We advocate minimum changes to the OMOP CDM and Standardized Vocabularies because we want to ensure minimum impact on OHDSI tools like Atlas, whilst providing a value-add SDTM-to-OMOP conversion with minimum data loss. We have proposed conventions introducing new concepts and modifiers, but no new CDM tables; and providing guidance for ETL developers where appropriate. Our proposals are built on OMOP CDM v6 and the Oncology extension, with v5.3.1 backward compatibility.

- Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database).
- Proposals submitted to the OHDSI community in July 2020.

Conventions proposal submitted to OHDSI

Group GitHub repository

Recent WG Presentation Slides


Schedule: Biweekly calls on Fridays, 7:30AM PT/9:30AM CT/10:30AM ET/3:30PM UK time on Teams here

Note on accessing Teams channel above:
* If you use the Teams desktop app and have multiple accounts, ensure you are already in the OHDSI Teams account before clicking the link above
* Alternatively, select the “web app” button in the link above for accessing meetings on your browser


WG co-leads: Mike Hamidi, Pfizer, US ( and Zhen Lin, Robot Bacon, US (

Active members

Name Organization Location
Rebecca Baker CDISC Austin, TX, USA
Melissa Cook Essex Management Boston, MA, USA
Mike Hamidi Pfizer USA
Michael Kallfelz Odysseus Data Services Inc. Berlin, Germany
Asiyah Yu Lin National Institute of Health;
National Center for Ontological Research
Bethesda, MD, USA
Zhen Lin Robot Bacon Houston, TX, USA ,
Katy Sadowski TrialSpark New York, NY, USA
Philip Solovyev Odysseus Data Services Inc. St. Petersburg, Russia
Anthony Sunjaya The George Institute for Global Health,
UNSW Sydney
Sydney, NSW, Australia
Ramona Walls Critical Path Institute Tucson, AZ, USA ,
Tom Walpole San Diego, CA, USA
Kenneth Wilkins National Institute of Health Bethesda, MD, USA
Ariana Winder nPhase, REDCap Cloud Bellefonte, PA, USA
Qi Yang IQVIA Plymouth Meeting, PA, USA

Other members

Name Organization Location
Eldar Allakhverdiiev Odysseus Data Services Inc. Cambridge, MA, USA
Sonia Araujo * IQVIA London, UK
Ted Bebi Medidata Boston, MA, USA
Lina Clover SAS Raleigh-Durham, NC, USA
Alexander Davydov Odysseus Data Services Inc. Cambridge, MA, USA
Shawn Dolley Open Global Health Arlington, Virginia, USA
Rhonda Facile CDISC Austin, Texas, USA
Vojtech Huser National Library of Medicine,
National Institutes of Health
Bethesda, MD, USA
Gregory Klebanov Odysseus Data Services Inc. Cambridge, MA, USA
Bess LeRoy CDISC Tucson, AZ, USA
James Liddil M2Gen Tampa, FL, USA
Maxim Moinat The Hyve Utrecht, The Netherlands
Alexandra Orlova Odysseus Data Services Inc. Cambridge, MA, USA
Joshua F. Ransom BEKHealth Inc Wayland, MA, USA
Chris Roeder School of Medicine, University of Colorado CO, USA
Cynthia Sung Bill & Melinda Gates Medical Research Institute Seattle, WA, USA
Emma Vos The Hyve Utrecht, The Netherlands
Andrew Williams Tufts Institute for Clinical Research
and Health Policy Studies
Boston, MA, USA

* Past leads

Want to contribute to the group? Opt-in here, or email Mike and/or Zhen.

projects/workgroups/clinicalstudy.txt · Last modified: 2021/11/15 14:56 by zhen