Protocol Representation Sub-Domain::InterventionalStudyProtocolVersion

: Public Class

Created:	6/19/2008 7:54:44 AM
Modified:	3/18/2019 11:23:38 PM

Project:
Author:	BRIDG SCC
Version:	1.0
Phase:	1.0
Status:
Complexity:	Easy
Difficulty:
Priority:
Multiplicity:
Advanced:
UUID:	{9CDD67F4-EC27-48f3-8B4A-BF626CD5020D}
Appears In:	UML-Based Comprehensive BRIDG Model Diagram, View PR: Protocol Representation, Study Versioning, View RG: Regulatory, SDTM IG v3.1.3, SDTM IG v3.2, Registering a Trial at ClinicalTrials.gov, Structured Protocol - Core Protocol Concepts

DEFINITION: A study protocol version in which study subjects or experimental units are assigned by an investigator based on a protocol to receive specific interventions. EXAMPLE(S): Version dates for "A Randomizaed Phase 3 Trial of Treatment 1 and Treatment 2 in Patients with Stage III Colon Cancer" VERSION 1: Activation February 10, 2004 VERSION 2: Addendum 7 January 4, 2008 VERSION 3: Addendum 8 May 12, 2008 OTHER NAME(S): NOTE(S): Study subjects or experimental units may receive diagnostic, therapeutic or other types of interventions. The assignment of the intervention may or may not be random. The study subjects or experimental units are then followed and biomedical and/or health outcomes are assessed.

Attributes
Associations From
Tagged Values
Constraints
Other Links

Attribute

Public CD
interventionTypeCode

Details:

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

Map:CTRPv3.8=InterventionalStudyProtocol.interventionTypeCode
Map:CTRRr3=PlannedIntervention.typeCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.interventionCategoryCode
Map:NCI CRF Standard=CDE 2008450v2.0: Prior Therapy Administered Type
Map:NCI CRF Standard=CDE 2542520v1.0: Prior Therapy Other Administered Specify
Map:NCI CRF Standard=CDE 65292v4.0: Systemic Therapy Type Specify
Map:NCI CRF Standard=CDE 64208v3.0: Therapy Name Type
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.2=TS.(INTTYPE) TSVALNF WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.2=TS,(INTTYPE) TSVCDVER WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.2=TS.(INTTYPE) TSVALCD WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.2=TS.(INTTYPE) TSVAL WHERE TSPARMCD = "INTTYPE"
Map:SDTM IGv3.2=TS.(INTTYPE) TSVCDREF WHERE TSPARMCD = "INTTYPE"

Notes:

DEFINITION: A coded value specifying the kind of intervention being studied. EXAMPLE(S): Drug, Radiation, Lifestyle OTHER NAME(S): NOTE(S): Relevant for categorization or when not conveying the details of the studied intervention.

Public ST
interventionDescription

Details:

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

Map:CTGOV=Intervention Description
Map:CTRPv1.0=InterventionalStudyProtocol.primaryPurposeCode
Map:CTRR=Description of investigational treatments
Map:CTRR=Intervention Description
Map:CTRRr3=InterventionalStudy.interventionDescription
Map:CTRv1.0=InterventionalStudyProtocolVersion.interventionDescription

Notes:

DEFINITION: A character string that provides the key details of the intervention. EXAMPLE(S): The details may distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). Interventions involving drugs may include dosage form, dosage, frequency and duration. (50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.) OTHER NAME(S): NOTE(S):

Public INT.NONNEG
interventionGroupQuantity

Details:

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

Map:CTGOV=Number of Arms
Map:CTRPv1.0=InterventionalStudyProtocol.numberOfInterventionGroups
Map:CTRPv3.8=InterventionalStudyProtocol.numberOfInterventionGroups
Map:CTRR=Number of Arms
Map:CTRRr3=InterventionalStudy.interventionGroupQuantity
Map:CTRv1.0=InterventionalStudyProtocolVersion.interventionGroupQuantity
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "NARMS"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "NARMS"
Map:SDTM IGv3.2=TS.(NARMS) TSVALNF WHERE TSPARMCD = "NARMS"
Map:SDTM IGv3.2=TS.(NARMS) TSVAL WHERE TSPARMCD = "NARMS"

Notes:

DEFINITION: An integer specifying the number of intervention groups. EXAMPLE(S): Enter 1 for single-arm study. OTHER NAME(S): Number of Arms NOTE(S): This attribute is potentially derivable once the study design has been defined.

Public CD
controlTypeCode

Details:

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

Map:CTRPv1.0=InterventionalStudyProtocol.controlType
Map:CTRR=Control
Map:CTRRr3=InterventionalStudy.controlTypeCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.controlTypeCode
Map:SDTM IGv3.1.2=TSVAL where TSPARMCD=TCNTRL
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.2=TS.(TCNTRL) TSVCDREF WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.2=TS.(TCNTRL) TSVALNF WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.2=TS.(TCNTRL) TSVCDVER WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.2=TS.(TCNTRL) TSVALCD WHERE TSPARMCD = "TCNTRL"
Map:SDTM IGv3.2=TS.(TCNTRL) TSVAL WHERE TSPARMCD = "TCNTRL"

Notes:

DEFINITION: A coded value specifying the kind of comparison or comparator against which the study treatment is evaluated. EXAMPLE(S): placebo, active, historical, uncontrolled, dose comparison OTHER NAME(S): NOTE(S):

Public CD
controlConcurrencyTypeCode

Details:

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

Map:CTRPv1.0=InterventionalStudyProtocol.controlConcurrencyType
Map:CTRR=Concurrency
Map:CTRRr3=InterventionalStudy.controlConcurrencyTypeCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.controlConcurrencyTypeCode

Notes:

DEFINITION: A coded value specifying the temporal relationships of the control to the study intervention. EXAMPLE(S): concurrent, historical, pre/post (patient owned control) OTHER NAME(S): NOTE(S):

Public CD
allocationCode

Details:

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

Map:CTGOV=Study Design Allocation
Map:CTOM=Protocol.randomizedIndicator
Map:CTRPv1.0=InterventionalStudyProtocol.allocationCode
Map:CTRPv3.8=InterventionalStudyProtocol.allocationCode
Map:CTRR=Randomization
Map:CTRRr3=InterventionalStudy.allocationCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.allocationCode
Map:SDTM IGv3.1.2=TSVAL where TSPARMCD=RANDOM
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.2=TS.(RANDOM) TSVAL WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.2=TS.(RANDOM) TSVCDVER WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.2=TS.(RANDOM) TSVCDREF WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.2=TS.(RANDOM) TSVALNF WHERE TSPARMCD = "RANDOM"
Map:SDTM IGv3.2=TS.(RANDOM) TSVALCD WHERE TSPARMCD = "RANDOM"

Notes:

DEFINITION: A coded value specifying the method of assigning experimental units to treatment or control groups. EXAMPLE(S): n/a, randomized controlled study, non-randomized study OTHER NAME(S): NOTE(S):

Public CD
blindingSchemaCode

Details:

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

Map:C3PR=Study.blindedIndicator
Map:CTGOV=Study Design Masking
Map:CTOM=Protocol.blindedIndicator
Map:CTR&Rr2=Trial design Double blind
Map:CTR&Rr2=Trial design Single blind
Map:CTR&Rr2=Trial design Parallel group
Map:CTRPv1.0=InterventionalStudyProtocol.blindingSchemaCode
Map:CTRPv3.8=InterventionalStudyProtocol.blindingSchemaCode
Map:CTRR=Blinding Design
Map:CTRRr3=InterventionalStudy.blindingSchemaCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.blindingSchemaCode
Map:SDTM IGv3.1.2=TSVAL where TSPARMCD=TBLIND
Map:SDTM IGv3.1.3=TS.TSVCDREF WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.1.3=TS.TSVCDVER WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.1.3=TS.TSVALCD WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.2=TS.(TBLIND) TSVCDREF WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.2=TS.(TBLIND) TSVALNF WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.2=TS.(TBLIND) TSVAL WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.2=TS.(TBLIND) TSVALCD WHERE TSPARMCD = "TBLIND"
Map:SDTM IGv3.2=TS.(TBLIND) TSVCDVER WHERE TSPARMCD = "TBLIND"
Map:WHO=Masking

Notes:

DEFINITION: A coded value specifying the type of masking used to ensure that the results are not biased by the study subjects or investigators. EXAMPLE(S): Double-blinded would indicate that both the investigator and the study subject would not know whether the intervention was a placebo or an active therapeutic intervention. Open Label, Double Blind, Single Blind OTHER NAME(S): NOTE(S):

Public DSET<CD>
blindedRoleCode

Details:

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

Map:CTGOV=Masking Role
Map:CTRPv1.0=InterventionalStudyProtocol.blindedRoleCode
Map:CTRPv3.8=InterventionalStudyProtocol.blindedRoleCode
Map:CTRR=Blinded Roles
Map:CTRRr3=InterventionalStudy.blindedRoleCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.blindedRoleCode
Map:WHO=Study Type Masking Who is Blinded

Notes:

DEFINITION: A coded value specifying the roles of individuals who are masked for single or double blind studies. EXAMPLE(S): subject, caregiver, investigator, outcomes assessor OTHER NAME(S): NOTE(S):

Public REAL
studyAgentRandomizationFraction

Details:

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

Map:CTRv1.0=InterventionalStudyProtocolVersion.randomizationQuotient

Notes:

DEFINITION: A number representing the quantity of study subjects in the overall study who receive at least one study agent (as opposed to placebo) divided by the quantity of subjects in the study overall - independent of dosage or other protocol variations. EXAMPLE(S): OTHER NAME(S): NOTE(S): This value can be thought of as the percentage of study subjects who will be exposed to the study agent(s), though it is expressed as a real number with a maximum value of 1.0.

Public BL
acceptsHealthyVolunteersIndicator

Details:

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

Map:CTGOV=Accepts Healthy Volunteers?
Map:CTOM=Accepts healthty volunteers
Map:CTRPv1.0=InterventionalStudyProtocol.acceptsHealthyVolunteersIndicator
Map:CTRPv3.8=StudyProtocol.acceptsHealthyVolunteersIndicator
Map:CTRRr3=InterventionalStudy.acceptsHealthyVolunteersIndicator
Map:CTRv1.0=InterventionalStudyProtocolVersion.acceptsHealthyVolunteersIndicator

Notes:

DEFINITION: Specifies whether persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public BL
dataMonitoringCommitteeIndicator

Details:

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

Map:CTRPv3.8=StudyProtocol.dataMonitoringCommitteeAppointedIndicator
Map:CTRRr3=Study.dataMonitoringCommitteeIndicator

Notes:

DEFINITION: Specifies whether a data monitoring committee is appointed to the study. EXAMPLE(S): OTHER NAME(S): NOTE(S): Derived from the existence of an association between StudyProtocolVersion and StudyOversightAuthority where the associated OversightCommittee.typeCode= "data monitoring committee".

Public PQ.TIME
confirmedResponseMinimumDuration

Details:

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

Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "CRMDUR"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "CRMDUR"
Map:SDTM IGv3.2=TS.(CRMDUR) TSVALNF WHERE TSPARMCD = "CRMDUR"
Map:SDTM IGv3.2=TS.(CRMDUR) TSVAL WHERE TSPARMCD = "CRMDUR"

Notes:

DEFINITION: The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Public PQ.TIME
stableDiseaseMinimumDuration

Details:

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

Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "SDMDUR"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "SDMDUR"
Map:SDTM IGv3.2=TS.(SDMDUR) TSVAL WHERE TSPARMCD = "SDMDUR"
Map:SDTM IGv3.2=TS.(SDMDUR) TSVALNF WHERE TSPARMCD = "SDMDUR"

Notes:

DEFINITION: The protocol specified minimum amount of time needed to meet the definition of stable disease. EXAMPLE(S): OTHER NAME(S): NOTE(S):

Element	Source Role	Target Role
«DEPRECATED» RelevantRegulation Class	Name: governingRelevantRegulation	Name: governedInterventionalStudyProtocolVersion
Details: DESCRIPTION:<br/>Each RelevantRegulation always governs one InterventionalStudyProtocolVersion. Each InterventionalStudyProtocolVersion might be governed by one or more RelevantRegulation.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>

Tag	Value
Map:C3PR	Study.type
Details:
Map:CTGOV	Study Type - Interventional
Details:
Map:CTRPv1.0	InterventionalStudyProtocol
Details:
Map:CTRPv3.8	InterventionalStudyProtocol
Details:
Map:CTRR	Study Type
Details:
Map:CTRRr3	Study.typeCode
Details:
Map:CTRRr3	InterventionalStudy
Details:
Map:CTRRr3	Study.typeCode
Details:
Map:CTRv1.0	InterventionalStudyProtocolVersion
Details:
Map:WHO	Study Type
Details:

Constraint	Type	Status
blindedRoleCode Qualifier	Invariant	Approved
Details: For blindedRoleCode, the roles identified map to StudySubject, StudyInvestigator, Assessor, and AssociatedBiologicEntity.<br/>
dataMonitoringCommitteeIndicator Qualifier	Invariant	Approved
Details: If dataMonitoringCommitteeIndicator = "false", there must not be an associated OversightCommittee (via StudyOversightAuthority) with typeCode = "data monitoring committee".<br/>

Object	Type	Connection	Direction	Notes
StudyProtocolVersion	Class	Generalization	To	DESCRIPTION: Each InterventionalStudyProtocolVersion always specializes one StudyProtocolVersion. Each StudyProtocolVersion might be specialized by one InterventionalStudyProtocolVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):