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CDER Data
Standards Manual
The CDER Data Standards Manual (DSM) is a compilation of standardized
nomenclature monographs that have been reviewed and approved by the CDER Nomenclature
Standards Committee (NSC). These CDER nomenclature standards are considered binding upon
all new automated databases, and upon all existing automated databases when undergoing a
major redesign. Use of the nomenclature standards are strictly voluntary for static
existing databases. Some of the current CDER automated databases that use these
nomenclature standards include the Center-wide Oracle Management Information System
(COMIS), the Division Files System (DFS), the Drug Product Reference File (DPRF), the Drug
Registration and Listing System (DRLS), the Developers and Distributors System (DADS), the
Special Products On-Line Tracking System (SPOTS), and the Phase 4 Tracking System.
The DSM is modeled after the Agency Data Standards Manual in format and content. Several
of DSM monographs for CDER have been jointly developed by the NSC and the Agency Data
Standards Committee, which is represented by each of the Centers, as well as OC and ORA.
DSM monographs may have been derived either wholly or in part from other nomenclature
standards settings bodies, as well, such as the International Conference on Harmonization
(ICH), the United States Pharmacopeia (USP), the United States Adopted Names Council
(USAN), the American Hospital Formulary Service (AHFS), the Chemical Abstracts Service
(CAS), the National Institutes of Standards and Technology (NIST), the International
Organization for Standardization (ISO), the American Society for Testing and Materials
(ASTM), US Census Bureau, US Postal Service, and the Central Intelligence Agency.
If you would like to propose a change to one of the DSM monographs, you must first complete a Vocabulary Change Request Form. The NSC meets as necessary to discuss proposed changes to the DSM. If you have any questions about the DSM or the NSC, please contact William A. Hess at 301-827-7865 or william.hess@fda.hhs.gov.
| Authority |
Monograph Number |
|
MaPP 7600.4 Nomenclature Standards Committee |
7600.4
|
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Date updated: August 1, 2008 |
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