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

DESCRIPTION

These data elements were developed from data submitted to the U.S. Food and Drug Administration in marketing applications for drugs to treat Schizophrenia.. They are meant to support the collection of data during a patient encounter within a clinical research study. The data elements include concepts for DSM IV and 5 diagnoses and their specifiers as well as mental health specific patient characteristics, symptomatology, and history.

ALTERNATIVE NAMES

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

TARGETS

• Quality Reporting Agencies
• Standards Development Organizations (SDOs)
• Regulatory Agency
• Pharmaceutical Vendors
• EHR, PHR Vendors
• Health Care IT Vendors
• Clinical Decision Support Systems Vendors
• Local and State Departments of Health
• Healthcare Institutions (hospitals, long term care, home care, mental health)

BENEFITS

• Standardizes the clinical data necessary for evaluating marketing applications for drugs to treat Schizophrenia.

IMPLEMENTATIONS/CASE STUDIES

• Clinical Data Interchange Consortium (CDISC) will use this standard as a foundation for their Study Data Tabulation Model (SDTM) Therapeutic Area User Guide (TAUG) to support the evaluation of marketing applications submitted to the U.S. Food and Drug Administration (FDA) for drugs to treat Schizophrenia.
• This work was made possible by grant number 1R24FD004271-01 from the FDA, an operating division of the Department of Health and Human Services (HHS). Its contents are solely the responsibility of the author and do not necessarily represent the official view of the FDA.

 

DEVELOPMENT BACKGROUND

The U.S. Food and Drug Administration (FDA) has a stated goal of standardizing disease-specific data elements in multiple therapeutic areas. Under this program and funded by grant number 1R24FD004271-01, data elements for Schizophrenia have been drafted.

The data elements were developed from a review of data collection forms from recent marketing applications submitted to the FDA for drugs to treat Schizophrenia as well as from forms for NIMH-funded studies.  Schizophrenia specific concepts were synthesized to form a set of distinct data elements, and definitions were drafted based on form context and existing standards, e.g., DSM-IV-TR, DSM 5. The data elements and their definitions were then carefully reviewed by a group of clinical thought leaders in Schizophrenia from academia and industry, and their feedback was incorporated. In addition, during balloting, feedback was sought from relevant clinical professional societies, with significant input received from the American Psychiatric Association (APA) and the International Society for CNS Clinical Trials and Methodology (ISCTM).

 

RELATED DOCUMENTS

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

(Download) (3.05 MB)

TOPICS

• Community-Based Health
• Decision Support
• Medical Records
• Public Health
• Regulated Products
• Regulated Studies
• Terminology

BALLOT TYPES

• Informative

STATUS DATE

2014-10-26

RESPONSIBLE WORK GROUP

PRODUCT TYPES

• ANSI-registered Technical Report
• Domain Analysis Model

STAKEHOLDERS

• Clinical Decision Support Systems Vendors
• EHR, PHR Vendors
• Health Care IT Vendors
• Healthcare Institutions
• Local and State Departments of Health
• Pharmaceutical Vendors
• Quality Reporting Agencies
• Regulatory Agency
• Standards Development Organizations (SDOs)

FAMILY

• V3

CURRENT STATE

• Stable

REALM

• Universal