: Public Class
Created: 6/19/2008 7:54:44 AM
Modified: 3/7/2015 12:27:59 AM
Project:
Advanced:
DEFINITION:<br /></p><p>A plan at a particular point in time for a pre-clinical or clinical study in which study subjects or experimental units are assigned by an investigator based on a protocol to receive specific interventions.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Version dates for "A Randomizaed Phase 3 Trial of Treatment 1 and Treatment 2 in Patients with Stage III Colon Cancer"<br /></p><p><br /></p><p>VERSION 1: Activation February 10, 2004 <br /></p><p>VERSION 2: Addendum 7 January 4, 2008<br /></p><p>VERSION 3: Addendum 8 May 12, 2008<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>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.<br /></p>
Attribute
Public CD
  interventionTypeCode
Details:
Map:CTRPv3.8=InterventionalStudyProtocol.interventionTypeCode
Map:CTRRr3=PlannedIntervention.typeCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.interventionCategoryCode
Map:NCI CRF Standard=CDE 2542520v1.0: Prior Therapy Other Administered Specify
Map:NCI CRF Standard=CDE 64208v3.0: Therapy Name Type
Map:NCI CRF Standard=CDE 65292v4.0: Systemic Therapy Type Specify
Map:NCI CRF Standard=CDE 2008450v2.0: Prior Therapy Administered Type
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of intervention being studied.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Drug, Radiation, Lifestyle#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Relevant for categorization or when not conveying the details of the studied intervention.#lt;br /#gt;#lt;/p#gt;
Public ST
  interventionDescription
Details:
Map:CTGOV=Intervention Description
Map:CTRPv1.0=InterventionalStudyProtocol.primaryPurposeCode
Map:CTRR=Intervention Description
Map:CTRR=Description of investigational treatments
Map:CTRRr3=InterventionalStudy.interventionDescription
Map:CTRv1.0=InterventionalStudyProtocolVersion.interventionDescription
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A character string that provides the key details of the intervention. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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).  #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public INT.NONNEG
  interventionGroupQuantity
Details:
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
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;An integer specifying the number of intervention groups.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Enter 1 for single-arm study.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Number of Arms#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;This attribute is potentially derivable once the study design has been defined.#lt;br /#gt;#lt;/p#gt;
Public CD
  controlTypeCode
Details:
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
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of comparison or comparator against which the study treatment is evaluated.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;placebo, active, historical, uncontrolled, dose comparison#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  controlConcurrencyTypeCode
Details:
Map:CTRPv1.0=InterventionalStudyProtocol.controlConcurrencyType
Map:CTRR=Concurrency
Map:CTRRr3=InterventionalStudy.controlConcurrencyTypeCode
Map:CTRv1.0=InterventionalStudyProtocolVersion.controlConcurrencyTypeCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the temporal relationships of the control to the study intervention.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;concurrent, historical, pre/post (patient owned control)#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  allocationCode
Details:
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
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the method of assigning experimental units to treatment or control groups.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;n/a, randomized controlled study, non-randomized study#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public CD
  blindingSchemaCode
Details:
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 Parallel group
Map:CTR&Rr2=Trial design Single blind
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:WHO=Masking
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the type of masking used to ensure that the results are not biased by the study subjects or investigators.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Open Label, Double Blind, Single Blind#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public DSET<CD>
  blindedRoleCode
Details:
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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the roles of individuals who are masked for single or double blind studies.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;subject, caregiver, investigator, outcomes assessor#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public REAL
  studyAgentRandomizationFraction
Details:
Map:CTRv1.0=InterventionalStudyProtocolVersion.randomizationQuotient
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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.#lt;br /#gt;#lt;/p#gt;
Public BL
  acceptsHealthyVolunteersIndicator
Details:
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:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;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. #lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public BL
  dataMonitoringCommitteeIndicator
Details:
Map:CTRPv3.8=StudyProtocol.dataMonitoringCommitteeAppointedIndicator
Map:CTRRr3=Study.dataMonitoringCommitteeIndicator
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Specifies whether a data monitoring committee is appointed to the study.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;Derived from the existence of an association between StudyProtocolVersion and #lt;br /#gt;#lt;/p#gt;#lt;p#gt;StudyOversightAuthority where the associated OversightCommittee.typeCode= "data monitoring committee".#lt;br /#gt;#lt;/p#gt;
Public PQ.TIME
  confirmedResponseMinimumDuration
Details:
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Public PQ.TIME
  stableDiseaseMinimumDuration
Details:
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The protocol specified minimum amount of time needed to meet the definition of stable disease.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;EXAMPLE(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;OTHER NAME(S):#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;NOTE(S):#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
RelevantRegulation
Class   		Name: governingRelevantRegulation
  		Name: governedInterventionalStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each RelevantRegulation always governs one InterventionalStudyProtocolVersion. Each InterventionalStudyProtocolVersion might be governed by one or more RelevantRegulation.<br /></p><p><br /></p><p>DEFINITION:<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p>
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 Study.typeCode
Details:
 
Map:CTRRr3 InterventionalStudy
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.
dataMonitoringCommitteeIndicator Qualifier Invariant Approved
Details:
If dataMonitoringCommitteeIndicator = "false", there must not be an associated OversightCommittee (via StudyOversightAuthority) with typeCode = "data monitoring committee".
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):