: Public Class
Created: 7/25/2007 9:23:04 AM
Modified: 8/26/2017 2:39:36 AM
Project:
Advanced:
DEFINITION:<br/>A goal that the study is aiming to achieve in terms of a scientific question to be answered by the analysis of data collected during the study.<br/><br/>EXAMPLE(S):<br/>To extend the life of study participants by at least 3 years.<br/>To determine efficacy of Drug X dose 1, dose 2, and dose 3 as measured by the percentage of subjects experiencing headache relief.<br/>To compare overall survival in subjects with [type of cancer] who have received [prior treatment] and who are randomized to treatment with either Combination A+B or single-agent B.  <br/>To select a Drug X dose for further evaluation based on comparison of the short-term antiviral activity, safety, and tolerability of different oral doses of Drug X in combination with Drug Y in HIV-1 infected therapy-na├»ve subjects.<br/>To compare the proportion of subjects developing a rash in subjects administered dermatological precautions  (DP) versus subjects administered usual care precautions (UC) during 12 weeks of treatment of Drug X in [disease description] subjects.<br/>To obtain exploratory descriptive information on the relationship of tobacco use, alcohol use and dietary patterns on toxicity and outcomes in males and females.<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>StudyProtocolVersion.purposeStatement, StudyProtocolVersion.primaryPurposeTypeCode and StudyObjective may sound similar in meaning but are distinct concepts in BRIDG. StudyProtocolVersion.purposeStatement, which is an broad explanation of why a study is being conducted (e.g. determine efficacy of a drug or procedure), differs from StudyProtocolVersion.primaryPurposeTypeCode which is a classification of the purpose or intent of the study (e.g. Prevention, Treatment, Quality of Life), and that differs from StudyObjective, which describes in a specific and measurable way what the study hopes to accomplish (e.g. extend life of subjects at least 3 years, reduce frequency of symptoms).<br/>
Attribute
Public CD
  typeCode
Details:
Map:SDTM IGv3.1.1=TS.TSPARMCD
Notes: DEFINITION:<br/>A coded value specifying the kind of study objective.<br/><br/>EXAMPLE(S):<br/>primary, secondary, tertiary, exploratory<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The examples given are the only allowable concepts for this attribute.<br/>
Public ST
  description
Details:
Map:CTR&Rr2=Trial main objective
Map:CTR&Rr2=Trial secondary objective
Map:CTRPv3.8=StudyObjective.outline
Map:CTRRr3=StudyObjective.description
Map:CTRv1.0=StudyObjective.description
Map:HSDBv1.0=[Study].Primary Purpose 'Other' value specification
Map:HSDBv1.0=[Study].Primary Purpose
Map:SDTM IGv3.1.1=TS.TSPARMCD
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=OBJPRIM
Map:SDTM IGv3.1.2=TS.TSVAL where TSPARMCD=OBJSEC
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OBJSEC"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OBJSEC"
Map:SDTM IGv3.1.3=TS.TSVALNF WHERE TSPARMCD = "OBJPRIM"
Map:SDTM IGv3.1.3=TS.TSVAL WHERE TSPARMCD = "OBJPRIM"
Notes: DEFINITION:<br/>The textual representation of the study objective.<br/><br/>EXAMPLE(S):<br/>The objective of the analysis is to evaluate the efficacy of study treatment versus placebo. The Alzheimer's Disease Assessment Scale - Cognitive Subscale, total of 11 items  [ADAS-Cog (11)] and the Video-referenced Clinician's Interview-based Impression of Change (CIBIC+) will serve as the primary efficacy instruments. Efficacy will be determined by testing for a statistically significant relationship between the change in both the ADAS-Cog (11) and CIBIC+ scores, and drug dose (0, low dose [54 mg], and high dose [81 mg]).<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/>The example above makes reference to content from more than just the StudyObjective class, rather also from classes closely related to it. However, in prose presentation, this is common practice. See BRIDG GForge Tracker #30649 and #31401.<br/>
Element Source Role Target Role
StudyProtocolVersion
Class  
Name: involvedStudyObjective
 
Name: involvingStudyProtocolVersion
 
Details:
DESCRIPTION:<br/>Each StudyObjective always is an aim of one StudyProtocolVersion.  Each StudyProtocolVersion might aim to achieve one or more StudyObjective.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Element Source Role Target Role
StudyOutcomeMeasure
Class  
Name: measuringStudyOutcomeMeasure
 
Name: measuredStudyObjective
 
Details:
DESCRIPTION:<br/>Each StudyOutcomeMeasure always measures one or more StudyObjective.  Each StudyObjective always is measured by one or more StudyOutcomeMeasure.<br/><br/>DEFINITION:<br/><br/>EXAMPLE(S):<br/><br/>OTHER NAME(S):<br/><br/>NOTE(S):<br/><br/>
Tag Value
Map:CTRPv3.8 StudyObjective
Details:
 
Map:CTRR Objectives
Details:
 
Map:CTRRr3 StudyObjective
Details:
 
Map:CTRv1.0 StudyObjective
Details:
 
Constraint Type Status
description Unique Qualifier Invariant Approved
Details:
A StudyObjective.description must be unique within the context of the StudyProtocolVersion to which it is associated.<br/>