The Schizophrenia and Major Depressive Disorder Standard Data Element projects, led by Principal Investigator Meredith Zozus, PhD of Duke Translational Medicine Institute (DTMI), have passed the informative Health Level 7 (HL7) ballot process and will be submitted to the HL7 Technical Steering Committee for publication approval in the spring of 2014. These two projects were funded by the Food and Drug Administration’s grants in accordance with the Prescription Drug User Fee Act (PDUFA) to create 58 therapeutic area standards for regulated clinical research through open consensus-based standards development organizations.
Duke Translational Medicine Institute (DTMI), in partnership with Duke Center for Health Informatics (DCHI) and Duke Clinical Research Institute (DCRI), spent 2.5 years developing these standards with the assistance of an international clinical community that served on the clinical expert review committee, the FDA’s Center for Drug Evaluation and Research’s Mental Health Division, and professional societies including the International Society of Clinical Trials and Methodology and the American Psychiatric Association. In addition to the case reports forms provided by the FDA, the National Institute of Mental Health (NIMH) also provided their research forms and questionnaires to assist with the effort.
The project team included PI Meredith Zozus, PhD, project leader Anita Walden, informaticians James Topping and Cindy Kluchar, clinical psychologist Robert Zozus, PhD, modeler consultant Mead Walker, and student modeler Maryam Younes, clinician Mimi Kessler, and other informatics students who met weekly as a project team of the HL7 Clinical Interoperability Council work group.
The Major Depressive Disorder project was launched and balloted a year after the Schizophrenia project. It built upon the prior work to create a model and data elements that harmonized with the Schizophrenia (DAM). There are 38 core standard data elements common between between both standards, which form the foundation for a standard Mental Health DAM.
The next steps include transitioning the projects to Clinical
Data Interchange Standards Consortium (CDISC) for incorporation of the data
elements into the Study Data Tabulation Model (SDTM), and producing a
mental health SDTM User’s Guide. The data elements will be stored in the
National Cancer Institute’s metadata repository, caDSR, for public
Acknowledgements: The work presented here in Schizophrenia
(R24FD004271-01, R24 FD004271 01S1) and Major Depressive Disorder
(R24FD004656-01) was made possible by funding from the Food and Drug
Administration (FDA), a component of the Department of Health and Human
Services (HHS). The presentation contents are solely the responsibility
of the author and do not necessarily represent the official view of the