Common Data Model Harmonization: Real World Data to FDA Submission with FHIR
FDA, CDC, NIH (NCATS) 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.
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.