HL7 Version 3 Domain Analysis Model: Bipolar Disorder, Release 1 - US Realm

DESCRIPTION

The Food and Drug Administration is standardizing mental health data elements for Bipolar and General Anxiety disorder for drug authorization submissions. Even though there is some standardization across the industries there are variations which make it challenging to aggregate data across data sets from various sponsors. This project will attempt to standardize data elements so that data can be aggregated in the FDA information systems for improved review and analysis of information.

ALTERNATIVE NAMES

HL7 Version 3 Domain Analysis Model: Bipolar Disorder, Release 1 - US Realm may also go by the following names or acronyms:

BENEFITS

• Provides a data standard to increase review consistency and enable evaluations across the drug lifecycle.
• Supports the FDA Center for Drug Evaluation and Research’s (CDER) key regulatory functions, including pre-market review, post-market safety, oversight of drug quality, and oversight of drug promotion.
•  Enables interoperability between healthcare and research by defining data elements for drug development and regulatory decision-making with knowledge of the larger healthcare context
• Thus, the specific aim of this research have been:
  • Aim 1: Identify and document candidate data elements used for regulatory decision-making in Bipolar Disorder. ·
  • Aim 2: Define and standardize data elements through open standards development processes and create a suggested research representation in the CDISC SDTM model.
  • Aim 3: Demonstrate how curated knowledge sources can be used in conjunction with standard data elements to increase information gained from data submitted for regulatory decision-making.

IMPLEMENTATIONS/CASE STUDIES

This standard was developed by the clinical community. A Clinical Expert Review Committee (CERC) convened by the Food and Drug Administration (FDA) provided clinical expertise on the scope, the data elements and their definitions, and the assessment tools. The National Institute of Mental Health (NIMH) provided content for consideration, and the clinical professional societies reviewed and contributed to the content. The Duke Translational Medicine Institute, in partnership with Health Level Seven's (HL7) Clinical Interoperability Council working group, worked closely with the FDA to facilitate and manage the project. The following professional societies contributed:

• American College of Neuropsychopharmacology (ACNP)
• American Psychiatric Association (APA)
• American Society of Clinical Psychopharmacology (ASCP)
• International Society for CNS Clinical Trials and Methodology (ISCTM)
• National Institutes of Health (NIH)

DEVELOPMENT BACKGROUND

*Research reported in this publication was supported by the FDA Center for Drug Evaluation Research (CDER), FDA grant number U24FD005242. The content is solely the responsibility of the authors and does not necessarily represent the official views of the FDA.

RELATED DOCUMENTS

HL7 Version 3 Domain Analysis Model: Bipolar Disorder, Release 1 - US Realm

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BALLOT TYPE

• Informative

STATUS DATE

2020-12-22

RESPONSIBLE WORK GROUP

PRODUCT TYPE

• Domain Analysis Model

STAKEHOLDERS

• Clinical and Public Health Laboratories
• EHR, PHR Vendors
• Emergency Services Providers
• Healthcare Institutions
• Local and State Departments of Health
• Regulatory Agency

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• US Realm