: Public Class
Created: 2/9/2006 9:23:40 AM
Modified: 9/30/2013 1:38:01 AM
Project:
Advanced:
DEFINITION:<br /></p><p>An organized representation of information in publishable, human-readable form (that persists over time).<br /></p><p><br /></p><p>EXAMPLE(S):<br /></p><p>Study Protocol, Adverse Event Report, Expedited Adverse Event Report, Institutional Review Board (IRB) Report, X-Ray Report, Lab Summary Report, Autopsy Report<br /></p><p><br /></p><p>OTHER NAME(S):<br /></p><p><br /></p><p>NOTE(S):<br /></p><p>A document groups the various document versions and has the following characteristics: 1) Stewardship, 2) Potential for authentication, 3) Wholeness, 4) Human readability, 5) Persistence, 6) Global vs local context (the person that signs it is the author of all sections unless otherwise noted).<br /></p><p><br /></p><p>Regulatory processes require the submission of documents from the Applicant to the Regulatory Authority. These documents are varied in focus and are often defined by the field of study or by the regulatory application requirements of the region or Regulatory Authority (e.g., Integrated Summary of Safety, Pharmacokinetics Written Summary). <br /></p>
Attribute
Public CD
  typeCode
Details:
Map:AE=AmendmentFollowUpReport
Map:C3PRv2.9=StudyVersion.amendmentType
Map:CTRPv1.0=Document.typeCode
Map:CTRPv3.8=Document.typeCode
Map:CTRRr3=Document.typeCode
Map:CTRv1.0=Document.typeCode
Map:HL7SD=ReplacementOf1.typeCode
Map:ICSRr2=document.code (in IndividualCaseSafetyReport)
Map:ICSRr2=ControlActEvent.code (in IndividualCaseSafetyReport)
Map:LSDAM=Document.typeCode
Map:LSDAMv2.2.3Plus=Document.typeCode
Map:RPS1=Documentation.context
Map:Statistics v1.0=Document.typeCode
Notes: DEFINITION:#lt;br /#gt;#lt;/p#gt;#lt;p#gt;A coded value specifying the kind of document.#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;amendment, background material, guide, Data Clarification Form (DCF), regulatory record  (see description in NOTE(S) section)#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;In RPS, this is the code that specifies how the file is to be used within the submission process (e.g. Protocol, Summary Introduction). Also known as context of use.#lt;br /#gt;#lt;/p#gt;#lt;p#gt;#lt;br /#gt;#lt;/p#gt;#lt;p#gt;The example "regulatory record" is described as "a document that meets a recording requirement of a regulatory authority and must be retained in accordance with that agency's records retention requirements".#lt;br /#gt;#lt;/p#gt;
Element Source Role Target Role
DocumentVersion
Class   		Name: versioningDocumentVersion
  		Name: versionedDocument
 
Details:
DESCRIPTION:<br /></p><p>Each DocumentVersion always is a version of one Document. Each Document might have as a version one or more DocumentVersion.<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>
DocumentIdentifier
Class   		Name: identifyingDocumentIdentifier
  		Name: identifiedDocument
 
Details:
DESCRIPTION:<br /></p><p>Each DocumentIdentifier always identifies one Document. Each Document might be identified by one or more DocumentIdentifier.<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:AE Document
Details:
 
Map:C3PRv2.9 Consent
Details:
 
Map:CTRPv1.0 Document
Details:
 
Map:CTRPv3.8 Document
Details:
 
Map:CTRR Protocol Title
Details:
 
Map:CTRv1.0 Document
Details:
 
Map:ICSRr2 document (in IndividualCaseSafetyReport)
Details:
 
Map:LSDAM Document
Details:
 
Map:LSDAMv2.2.3Plus Document
Details:
 
Map:RPS1 Documentation
Details:
 
Map:Statistics v1.0 Document
Details:
 
Object Type Connection Direction Notes
StudyProtocolDocument Class Generalization From DESCRIPTION: Each StudyProtocolDocument always specializes one Document. Each Document might be specialized by one StudyProtocolDocument. DEFINITION: EXAMPLE(S): OTHER NAME(S): NOTE(S):