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Dr. GersingFDA, CDC, NIH (NCATS) are developing a FHIR based infrastructure that facilitates interactions with the four most prevalent Common Data Models (CDMs) - Sentinel , OMOP, i2b2/ACT and PCORNet - from a single portal. The infrastructure allows  investigators the ability to create a universal query that can be run against all four CDMs, a secure transport and aggregation of the cross CDM query results, and the ability to submit the results directly to the FDA as a CDISC STDM file.

Session details...   


Dr. Kenneth Gersing joined NCATS in 2016 as the Director of Informatics in the Division of Clinical Innovation and he became a federal employee in 2017. Dr. Gersing is a psychiatrist and informatics expert, and was the Director of Clinical Information Systems, Duke Department of Psychiatry, from 1997 to 2015. Dr. Gersing was the creator Mindlinc Inc., a medical software company.  Mindlinc includes informatics applications highly relevant to activities within DCI and ORDR, such as an electronic medical record, a research data warehouse, and electronic data capture and patient reported outcomes for use in clinical trials.  At NCATS, Dr. Gersing will focus on informatics, and help advance the integration of health and research data, and promote the use of cutting edge informatics to advance the translation from discovery to health benefit.


Topic:  Common Data Model Harmonization: Real World Data to FDA Submission with FHIR

Speaker:  Kenneth Gersing, M.D., Director of Informatics, Division of Clinical Innovation, National Center for Advancing Translational Sciences (NCATS), National Institutes of Health

Date: February 13, 2019

Time: 11:00 a.m. – 12:00 p.m.

Room: TE406


Event Number: 730 622 061

Event Password: $Peakerseries19

You are invited to listen to Dr. Gersing's presentation in the NCI Shady Grove Building on Medical Center Drive or via WebEx. Dr. Gersing will present remotely via WebEx.

Presentation: A screencast of the presentation will be available for viewing after the event on the  NCI CBIIT Speaker Series YouTube Playlist

About the NCI CBIIT Speaker Series:

The National Cancer Institute (NCI) Center for Biomedical Informatics and Information Technology (CBIIT) Speaker Series presents talks from innovators in the research and informatics communities. The biweekly presentations allow thought leaders to share their work and discuss trends across a diverse set of domains and interests. The goals of the Speaker Series are: to share leading-edge research; to inform the community of new tools, trends, and ideas; to inspire innovation, and to provide a forum from which new collaborations can begin. For additional information, including past speaker series presentations, visit the  CBIIT Speaker Series page.

Individuals with disabilities who need reasonable accommodation to participate in this program should contact the Office of Space and Facilities Management (OSFM) at 240-276-5900 or the Federal TTY Relay number 1-800-877-8339.

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