: Public Class
Created: 5/21/2010 12:35:10 PM
Modified: 3/23/2015 3:22:11 PM
Project:
Advanced:
DEFINITION:<br /></p><p>A representation of a particular edition or snapshot of a document containing a study protocol as it exists at a particular point in time.<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Version 3 of a breast cancer protocol.<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p>Amendment<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>The term "protocol" is somewhat overloaded and must be qualified to provide semantic context.  Therefore the term "study protocol" was chosen to disambiguate it from other protocols. The notion of a study protocol includes (but is not limited to) the design, statistical considerations, activities to test a particular hypothesis or answer a particular question that is the basis of the study, characteristics, specifications, objective(s), background, pre-study/study/post-study portions of the plan (including the design, methodology, statistical considerations, organization).  The study may be of any type that involves subjects, including prevention, therapeutic, interventional or observational.  Subjects involved in the study protocol may be biological entities (human, animal, specimen, tissue, organ, etc.) or products. The study protocol is related to other supporting documents, including (but not limited to) informed consent documents, case report forms (CRFs), regulatory and approval documentation, correlative studies, etc. (via the inherited association to DocumentVersionRelationship).  The complete notion of the study protocol is represented in BRIDG by the classes StudyProtocol, StudyProtocolVersion, StudyProtocolDocument, StudyProtocolDocumentVersion, StudyConduct and all their associations.<br /></p><p>- The StudyProtocol class represents the content of the study protocol which includes characteristics and plan of the study which can be distilled into or abstracted from a version of the study protocol document and can exist even before the information is put into document form.<br /></p><p>- The StudyProtocolVersion class represents the details of the study protocol that may change over time.<br /></p><p>- The StudyProtocolDocument class represents the document form of the study protocol and is a grouping of the various study protocol document versions.<br /></p><p>- The StudyProtocolDocumentVersion class represents the document form of the study protocol version and is the details of the study protocol document that may change over time.<br /></p><p>- The StudyConduct class represents the execution of a study based on a study protocol definition which includes the scheduled and performed activities that are subject-specific as well as study-level and site-level activities.<br /></p><p><br /></p><p>The term "Amendment" needs to be disambiguated since it sometimes refers to the amended version of the protocol (StudyProtocolDocumentVersion) and other times refers to the summary of changes (AmendmentChangeSummaryVersion).<br /></p>
Attribute
Public ST
  publicTitle
Details:
Map:AE=Study.name
Map:C3PR=Study.shortTitleText
Map:C3PRv2.9=StudyVersion.shortTitleText
Map:caAERSv2.2=Study.shortTitleText
Map:CTGOV=Brief Title
Map:CTOM=Protocol.shortTitleText
Map:CTR&Rr2=Title of the trial for lay people
Map:CTRPv1.0=StudyProtocol.publicTitle
Map:CTRPv1.0=ObservationalStudyProtocol.publicTitle
Map:CTRPv1.0=InterventionalStudyProtocol.publicTitle
Map:CTRPv3.8=StudyProtocol.publicTitle
Map:CTRR=Protocol Short Title
Map:CTRRr3=StudyProtocolDocument.publicTitle
Map:CTRv1.0=StudyProtocolDocumentVersion.publicTitle
Map:HSDBv1.0=[Study].Study Short Title
Map:LabViewer2.2=Study.shortTitle
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=TITLE
Map:WHO=Public Title
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The title of the document intended for the general population.#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 official title for E-3108 is "A Phase II Prospective Trial Correlating Progression Free Survival With CYP2D6 Activity in Patients With Metastatic Breast Cancer Treated With Single Agent Tamoxifen" and the public title is "Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer" for the August 2013 Version.#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 ST
  publicDescription
Details:
Map:C3PR=Study.precisText
Map:C3PRv2.9=StudyVersion.descriptionText
Map:caAERSv2.2=Study.descriptionText
Map:CTGOV=Brief Summary
Map:CTOM=Protocol.descriptionText
Map:CTOM=Protocol.precisText
Map:CTRPv1.0=InterventionalStudyProtocol.publicDescription
Map:CTRPv1.0=StudyProtocol.publicDescription
Map:CTRPv1.0=ObservationalStudyProtocol.publicDescription
Map:CTRPv3.8=StudyProtocol.publicDescription
Map:CTRR=Study synopsis
Map:CTRRr3=Study.briefSummary
Map:CTRRr3=StudyProtocolDocument.publicDescription
Map:CTRv1.0=StudyProtocolDocumentVersion.publicDescription
Map:FDA HL7 SD SD DSTU2012=StudyProtocol.text
Map:HSDBv1.0=[Study].Study Public Description
Map:LabViewer2.2=Study.precisText
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual summary of a document version intended for the general population.#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 public description of the August 2012 version of E-3108 is "RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight cancer by blocking the use of estrogen by tumor cells.#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 ST
  scientificDescription
Details:
Map:C3PR=Study.descriptionText
Map:C3PRv2.9=StudyVersion.precisText
Map:caAERSv2.2=Study.precisText
Map:CTGOV=Detailed Description
Map:CTRPv1.0=InterventionalStudyProtocol.scientificDescription
Map:CTRPv1.0=StudyProtocol.scientificDescription
Map:CTRPv1.0=ObservationalStudyProtocol.scientificDescription
Map:CTRPv3.8=StudyProtocol.scientificDescription
Map:CTRRr3=Study.detailedDescription
Map:CTRv1.0=StudyProtocolDocumentVersion.scientificDescription
Map:HSDBv1.0=[Study].Study Scientific Description
Map:PSCv2.6=Study.longTitle
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The textual summary of a document version that includes extended scientific or technical information.#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;Part of the scientific description of the August 2012 version of E-3108 is "OBJECTIVES: Primary -To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate."#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
StudyProtocolVersion
Class   		Name: containingStudyProtocolDocumentVersion
  		Name: containedStudyProtocolVersion
 
Details:
DESCRIPTION:<br /></p><p>Each StudyProtocolDocumentVersion always contains one StudyProtocolVersion. Each StudyProtocolVersion might be the contents of one StudyProtocolDocumentVersion.<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:caAERSv2.2 Study
Details:
 
Map:CTRv1.0 StudyProtocolDocumentVersion
Details:
 
Constraint Type Status
is a version of Qualifier Invariant Approved
Details:
For a given StudyProtocolDocumentVersion, the StudyProtocol represented by the StudyProtocolDocument being versioned as the StudyProtocolDocumentVersion must be the same as the StudyProtocol whose StudyProtocolVersion is contained by the StudyProtocolDocumentVersion.
DocumentAuthor actualIndicator Qualifier Invariant Approved
Details:
Only Person (via HealthcareProvider or ResearchStaff) with actualIndicator = "true" is valid for the DocumentAuthor of a StudyProtocolDocumentVersion.
Object Type Connection Direction Notes
DocumentVersion Class Generalization To DESCRIPTION: Each StudyProtocolDocumentVersion always specializes one DocumentVersion. Each DocumentVersion might be specialized by one StudyProtocolDocumentVersion. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):