Stability Data Standard Terminology Files

The Stability Data Standards (Stability) terminology files provided here supported the cooperative efforts of the Food & Drug Administration (FDA) and Health Level Seven (HL7) to develop terminology that facilitates the processing and review of stability data. The efforts are described more fully on the FDA Stability Data Standard web page and the HL7 Drug Stability Reporting web page.

Archived Stability terminology files are available for download from this NCI EVS ftp site (https://evs.nci.nih.gov/ftp1/Stability/Archive) in three formats: .xls,.txt and.xml

Each file has column headers on the first row:

Spreadsheet Column Content Description

NCIt Subset Code The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.

Stability Subset Preferred Term The Stability preferred term attached to the subset concept.

NCIt Concept Code A unique and permanent identifier attached to every concept. The actual string carries no information other than to provide a machine readable piece of identification to every concept.

NCIt Preferred Term The most recognized and widely used term.

NCIt Definition A text definition of the term created by an NCI EVS subject matter expert.

Stability Preferred Term The term chosed by the Stability group for use as their Preferred Term.

Stability Definition A text definition of the term created by the Stability group.

Spreadsheet Column	Content Description
NCIt Subset Code	The NCIt concept code attached to the subset concept. NCIt Codes are unique strings that begin with a C and are followed by a series of digits.
Stability Subset Preferred Term	The Stability preferred term attached to the subset concept.
NCIt Concept Code	A unique and permanent identifier attached to every concept. The actual string carries no information other than to provide a machine readable piece of identification to every concept.
NCIt Preferred Term	The most recognized and widely used term.
NCIt Definition	A text definition of the term created by an NCI EVS subject matter expert.
Stability Preferred Term	The term chosed by the Stability group for use as their Preferred Term.
Stability Definition	A text definition of the term created by the Stability group.

Stability terminology is bundled into subsets, identified by code and name in the first two columns of each row. These are the names of the subsets and definitions supplied by the Stability Data Standards group:

Subset Name Subset Description

Stability Container Closure System Terminology The closure system of the container.

Stability Container Type Terminology As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA implementation, only the "display Name" (i.e., the product name) is mandatory, the code values might be provided if available.

Stability Product Form Terminology This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other submissions like SPL).

Stability Product Identifier Terminology This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is mandatory; the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established.

Stability Study Data File Reason Terminology This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an "Annual Report", "New Drug Application", "New Active Ingredient","Biologic License Application", "Premarket Approvals", or "Supplement to an Approved Application".

Stability Study Data File Type Terminology This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled study.

Stability Study Interpretation Terminology For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a result should not be greater (not more) than the given value). The commonly accepted nomenclature should be used here.

Stability Study Method Type Terminology A classification of the methods used in stability testing.

Stability Study Pause Description Terminology This code describes any "delay" that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen).

Stability Study Storage Condition Terminology The code provided represents a storage condition. Dependent of the internal company definitions this condition might be simple (e.g., 25°) or complex (e.g., 25° C/60% R.H. upright).

Stability Study Test Terminology This code describes the test performed during a study within the specification section.

Stability Study Type Terminology This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical.

Stability Substance Identifier Terminology The official code for a referenced substance (e.g., "acetylsalicylic acid"), as a single entity or part of a product (e.g., "aspirin").

Subset Name	Subset Description
Stability Container Closure System Terminology	The closure system of the container.
Stability Container Type Terminology	As reported entity or as part of a reported packaged product, this is the official code for a referenced package type. For FDA implementation, only the "display Name" (i.e., the product name) is mandatory, the code values might be provided if available.
Stability Product Form Terminology	This code describes the form of the reported product. Code values might be provided if available (e.g., when used in other submissions like SPL).
Stability Product Identifier Terminology	This is the code for the official product name. For FDA implementation, only the "displayName" (i.e., the product name) is mandatory; the code values might be provided if available (e.g., when used in other submissions like SPL). For NDA this is a new identifier. For ongoing studies the identifier should be identical to an already submitted code, so that a unique relationship can be established.
Stability Study Data File Reason Terminology	This code should indicate the type of application the data supports or whether the data is submitted to an existing application. The codes indicate that the data is part of an "Annual Report", "New Drug Application", "New Active Ingredient","Biologic License Application", "Premarket Approvals", or "Supplement to an Approved Application".
Stability Study Data File Type Terminology	This code should reflect if the file in hand is a standard data file for one storage condition or a partial file as part of a cycled study.
Stability Study Interpretation Terminology	For a single acceptance criterion (i.e., limit) this code describes how to relate the given value to a measured value, (e.g., a result should not be greater (not more) than the given value). The commonly accepted nomenclature should be used here.
Stability Study Method Type Terminology	A classification of the methods used in stability testing.
Stability Study Pause Description Terminology	This code describes any "delay" that happened during testing, e.g. none (Immediate) or freeze sample (Delayed Frozen).
Stability Study Storage Condition Terminology	The code provided represents a storage condition. Dependent of the internal company definitions this condition might be simple (e.g., 25°) or complex (e.g., 25° C/60% R.H. upright).
Stability Study Test Terminology	This code describes the test performed during a study within the specification section.
Stability Study Type Terminology	This code classifies the type of study performed on the given Research Subject, e.g., Commercial, Development, Clinical.
Stability Substance Identifier Terminology	The official code for a referenced substance (e.g., "acetylsalicylic acid"), as a single entity or part of a product (e.g., "aspirin").