Protocol Representation Sub-Domain::StudyAgent

: Public Class

Created:	1/5/2005 2:49:59 PM
Modified:	8/26/2017 2:39:35 AM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{814C9BBE-322A-4824-A666-2BEF9ECD1390}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View AE: Adverse Event, View PR: Protocol Representation, Study Versioning View, View SC: Study Conduct, Product, ClinicalTrials.gov

DEFINITION: A product that is being used or tested as part of a study. EXAMPLE(S): Tamoxifen used in a breast cancer study. Fish oil used in a heart health study. Artificial knee joints used in a joint replacement study. OTHER NAME(S): NOTE(S): If a study has study agents, presumably one or more of the StudyActivity will use the agent and have studyFocusedIndicator = "true".

Attributes
Associations To
Tagged Values

Attribute

Public CD
functionCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTOM=StudyAgent.investigationalIndicator
Map:CTR&Rr2=IMP Category
Map:CTRPv1.0=StudyProduct.leadProductIndicator
Map:CTRR=Comparator Description
Map:CTRRr3=StudyAgent.functionCode
Map:CTRv1.0=StudyAgent.functionCode
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=COMPTRT
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TRT

Notes:

DEFINITION: A coded value specifying how this agent is used in the study. EXAMPLE(S): lead agent, comparator agent, placebo, active control OTHER NAME(S): NOTE(S): This is important to know in multi-agent studies.

Public ST
blindedName

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:GSK MDRv1.0=GForge #27182 - Blinded Description for Product functioning as Study Agent

Notes:

DEFINITION: A non-unique textual identifier of a study agent to be used by participants from whom the identity of the study agent is hidden. This name is assigned within the context of a study so that products which blinded participants should not be able to distinguish between/among have the same blinded name. EXAMPLE(S): In a study for which the study agents are a drug product and a matching placebo, both the active product and the placebo might simply be called "Study Drug." In a study with two different investigational products and their matching placebos, the blinded names might be "Bottle A" and "Bottle B" or "100 mg tablet" and "25 mg tablet." OTHER NAME(S): NOTE(S):

Public DSET<CD>
firstInHumanRiskFactorCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to *
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=StudyAgent.firstInHumanRiskFactor

Notes:

DEFINITION: A coded value specifying the risk factors identified with administering the agent's active substance to humans for the first time in a study. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
firstInHumanIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=Study.typeCode
Map:CTRRr3=StudyAgent.firstInHumanIndicator

Notes:

DEFINITION: Specifies whether this is the first time an active substance of the agent is to be administered to humans in a study. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
expandedAccessIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTGOV=Has Expanded Access
Map:CTGOV=Study Type - Expanded Access and Has Expanded Access?
Map:CTRPv1.0=StudyProtocol.expandedAccessIndicator
Map:CTRPv1.0=ObservationalStudyProtocol.expandedAccessIndicator
Map:CTRPv1.0=InterventionalStudyProtocol.expandedAccessIndicator
Map:CTRPv3.8=StudyIndIde.expandedAccessIndicator
Map:CTRR=Expanded access indicator
Map:CTRRr3=StudyAgent.expandedAccessIndicator
Map:CTRv1.0=ExpandedAccessStudyProtocolVersion

Notes:

DEFINITION: Specifies whether the product (drug or device) is available for patients who are not adequately treated by existing therapy, who do not meet the eligibility criteria for enrollment, or who are otherwise unable to participate in a controlled study. Expanded Access is a mechanism that provides non-protocol access to experimental treatments, including protocol exception, single-patient IND, treatment IND, compassionate use, emergency use, continued access and parallel track. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
substitutionAllowedIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=StudyAgent.substitutionAllowedCode

Notes:

DEFINITION: Specifies whether this agent as identified by its active substance is permitted to be substituted by a local brand. EXAMPLE(S): The study protocol may specify the use of Paracetamol which could be substituted locally in the United States with any brand containing acetaminophen, including Tylenol and Panadol. OTHER NAME(S): NOTE(S):

Public BL
characteristicModifiedIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=StudyAgent.modifiedIndicator

Notes:

DEFINITION: Specifies whether the agent's characteristic have been modified from those approved in the marketing authorization in a way that could affect its quality. EXAMPLE(S): OTHER NAME(S): NOTE(S): Modification may include a change in pharmaceutical form (e.g. over-encapsulation, colour, dilution, re-tabletting for blinding etc.) or removal from the primary packaging and repacking (e.g. removal from a blister and putting in a bottle).

Public BL
pediatricFormulationIndicator

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTRRr3=DefinedActivity.subcategoryCode
Map:CTRRr3=DefinedActivity.categoryCode

Notes:

DEFINITION: Specifies whether the pharmaceutical form of the agent is intended for pediatric usage. EXAMPLE(S): A value of true may indicate that the agent is dissolvable, smaller, or grape flavored to be easily ingested by the pediatric population. OTHER NAME(S): NOTE(S):

Public CD
statusCode

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTOM=StudyAgent.statusCode
Map:CTRPv1.0=StudyProduct.statusCode
Map:CTRv1.0=StudyAgent.statusCode

Notes:

DEFINITION: A coded value specifying the phase in the lifecycle of the agent's association to a study. EXAMPLE(S): pending, active, complete, cancelled OTHER NAME(S): NOTE(S):

Public TS.DATETIME
statusDate

Details:

Alias:
Initial:
Stereotype:
Ordered:
Range:	Range:0 to 1
Transient:	False
Derived:	False
IsID:	False

Map:CTOM=StudyAgent.statusDate
Map:CTRPv1.0=StudyProduct.statusDateRange
Map:CTRv1.0=StudyAgent.statusDate

Notes:

DEFINITION: The date (and time) on which the status is assigned to the study agent. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
StudyProtocolVersion Class	Name: evaluatedStudyAgent	Name: evaluatingStudyProtocolVersion
Details: DESCRIPTION:<br/>Each StudyAgent always is evaluated by one StudyProtocolVersion. Each StudyProtocolVersion might be evaluating one or more StudyAgent.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Product Class	Name: performedStudyAgent	Name: performingProduct
Details: DESCRIPTION:<br/>Each StudyAgent always is a function performed by one Product. Each Product might function as one or more StudyAgent.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:caAERSv2.2	StudyAgent
Details:
Map:CTRPv1.0	StudyProduct
Details:
Map:CTRRr3	StudyAgent
Details:
Map:CTRv1.0	StudyAgent
Details: