: Public <<DEPRECATED>> Class
Created: 5/7/2012 9:22:21 AM
Modified: 8/26/2017 2:46:29 AM
Project:
Advanced:
DEFINITION:<br/>Specifies the jurisdictional law that may be applicable for registering the study to a clinical trial registry.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Attribute
Public CD
  code
Details:
Map:CTRRr3=Study.applicableRegulationCode
Notes: DEFINITION:<br/>A coded value specifying a regulation that requires the study to be registered. <br/><br/>EXAMPLE(S):<br/>US Food and Drug Administration regulation under section 351 of the Public Health Service Act or any of the following sections of the Federal Food, Drug and Cosmetic Act: 505, 510(k), 515, 520(m), and 522.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>
Public BL
  applicableIndicator
Details:
Map:CTRPv3.8=StudyProtocol.section801Indicator
Map:CTRPv3.8=StudyProtocol.FDAregulatedIndicator
Map:CTRRr3=Study.applicableClinicalTrialIndicator
Notes: DEFINITION:<br/>Specifies whether this study must be registered as required by applicable laws.<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/>Section 801 Clinical Trial<br/><br/>NOTE(S):<br/>Under US Public Law 110-85, Title VIII, Section 801, applicable drug trials include controlled clinical investigations, other than Phase I investigations, of a drug or biologic subject to US FDA regulation. Applicable device clinical trials are controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and pediatric postmarket surveillance. <br/>
Element Source Role Target Role
InterventionalStudyProtocolVersion
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:CTRPv3.8 (model integrity)
Details:
 
Map:CTRRr3 (model integrity)
Details: