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**Objective**: To allow adequate representation of clinical trial data in OMOP. | **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. | + | **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. | + | **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. |
- | **Status**: | + | **Status**:\\ |
- | - Proposals submitted to the OHDSI community in July 2020. | + | - Proposals submitted to the OHDSI community in July 2020.\\ |
- Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database). | - Currently applying our proposed conventions to the PHUSE database (a synthetic SDTM database). | ||
- | **WG Lead**: Sonia Araujo, IQVIA, London, UK (sonia.araujo@iqvia.com) | + | </WRAP> |
- | **Current Members** | ||
- | ^ Name ^ Organization & Location ^ | ||
- | | Alexander Davydov | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | Alexandra Orlova | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | Andrew Williams | Tufts Institute for Clinical Research and Health Policy Studies, Boston, MA, USA | | ||
- | | Asiyah Yu Lin | Center for Devices and Radiological Health, FDA, Silver Spring, MD, USA; National Center for Ontological Research, Buffalo, New York, USA | | ||
- | | Bess LeRoy | CDISC, Tucson, AZ, USA | | ||
- | | Chris Roeder | School of Medicine, University of Colorado, CO, USA | | ||
- | | Cynthia Sung | Bill & Melinda Gates Medical Research Institute, Seattle, WA, USA | | ||
- | | {nowrap|Eldar Allakhverdiiev} | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | Emma Vos | The Hyve, Utrecht, The Netherlands | | ||
- | | Gregory Klebanov | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | James Liddil | M2Gen, Tampa, FL, USA | | ||
- | | Joshua F. Ransom | BEKHealth Inc, Wayland, MA, USA | | ||
- | | Katy Sadowski | TrialSpark, New York, New York, USA | | ||
- | | Lina Clover | SAS, Raleigh-Durham, NC, USA | | ||
- | | Maxim Moinat | The Hyve, Utrecht, The Netherlands | | ||
- | | Michael Kallfelz | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | Mike Hamidi | CDISC, Audubon, PA, USA | | ||
- | | Philip Solovyev | Odysseus Data Services Inc., Cambridge, MA, USA | | ||
- | | Rebecca Baker | CDISC, Austin, Texas, USA | | ||
- | | Rhonda Facile | Elligo, Austin, Texas, USA | | ||
- | | Sonia Araujo | IQVIA, London, UK | | ||
- | | Ted Bebi | Medidata, Boston, MA, USA | | ||
- | | Tom Walpole | Trials.ai, San Diego, CA, USA | | ||
- | | Vojtech Huser | National Library of Medicine, National Institutes of Health, Bethesda, MD, USA | | ||
- | </WRAP> | + | ==== Membership ==== |
+ | |||
+ | **WG lead**: Sonia Araujo, IQVIA, London, UK (sonia.araujo@iqvia.com) | ||
+ | |||
+ | **Current members**\\ | ||
+ | {{:projects:workgroups:currentmembers_oct_2020_.png?600|}} | ||