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Cancer Data Standards Repository (caDSR) in the Context of Clinical Trials
Cancer Data Standards Repository (caDSR) in the Context of Clinical Trials
How is caDSR helping CCR collect and report clinical trials data?
The case of the Central Cancer Clinical Database (C3D)
How is caDSR helping CCR collect and report clinical trials data?
The case of the Central Cancer Clinical Database (C3D)
NCICB Jamboree February 26, 2003
or
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Agenda: caDSR in Clinical TrialsAgenda: caDSR in Clinical Trials
• caDSR Tools• caDSR Data Model• Implementing CDEs in Clinical• Central Cancer Clinical Database (C3D)
– RDC– Discoverer
• caDSR Tools• caDSR Data Model• Implementing CDEs in Clinical• Central Cancer Clinical Database (C3D)
– RDC– Discoverer
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caDSR ToolscaDSR Tools
CRT
CRFsQuestions
Valid Values
•Web Interface•PL/SQL Web Toolkit•9i Application Server•AC-centric
•Web Interface•Java•Tomcat
•Web Interface•Java •9i Application Server•DE–centric•XML / Excel Download
•Web Interface•Java •9i Application Server•DE-centric
CDE Curation
CDE Browser
•Client/Server•Excel/VB/PL/SQL•DE-centric
CRFquestions
•Client/Server•Excel/VB/PL/SQL•CRF-centric
Oracle caDSRDatabase
•Web Interface•Java•Tomcat
R
R
R
R
CRUD
CRUD
R
C
CUD
•Client/Server•Java•AC-centric
XML Loader
C
1
2
6
5
34
7
8
9
10
11
12
R
CRF questions / DE
caDSR
CRF Loader
EVS
CCRR
CRF questions / DEMatches
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caDSR Core ModelcaDSR Core Model
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Property
Context
RepresentationData Element
Concept
Conceptual Domain
Permissible Values
Value Domain
caDSR Core Model (Abbreviated)caDSR Core Model (Abbreviated)
Value Meanings
Administered ComponentAdministered Component To Be
List of Values
Data Element
ObjectClass
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C3D – Built around Oracle ClinicalC3D – Built around Oracle Clinical
• Clinical research system for pharmaceutical industry• Supports any kind of study in all therapeutic areas• Expedites the regulatory approval process by reducing
cycle times• Four subsystems
– Study design and management– Study data definition– Data capture and validation– Access and reporting
• Clinical research system for pharmaceutical industry• Supports any kind of study in all therapeutic areas• Expedites the regulatory approval process by reducing
cycle times• Four subsystems
– Study design and management– Study data definition– Data capture and validation– Access and reporting
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Loading CDEs into Oracle ClinicalLoading CDEs into Oracle Clinical
Oracle Clinical
Maintain GLIB Elements
OracleClinicalRepository
Global LibraryElements Web
Browser
caDSRRepository
ManualExtract Program
MSExcel (.xls)Spreadsheet
SQL*Loader
Tables:Nci_cdeNci_cde_dvgNci_cde_dvg_valuesNci_cde_questionsNci_cde_question_cat_rel
Pgms:Cde2dvgsCde2dvg_valuesCde2questions
Tables:Discrete_value_groupsDiscrete_valuesQuestionsQuestion_Category_Relations
Oracle RDBMS
PL/SQL programs
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Loading CDEs into Oracle Clinical (detail)Loading CDEs into Oracle Clinical (detail)
caDSRRepository
ManualExtract Program
MSExcel (.xls)Spreadsheet
NCI_CDE
SQL*Loader
Cde2dvgs.mig_data
Cde2questions.get_data
Oracle Clinical
Cde2dvg_values.mig_data
Cde2questions.mig_data
Cde2dvgs.get_dataCde2dvg_values.get_data
Nci_cde_dvg Nci_cde_dvg_values Nci_cde_questions Nci_cde_question_cat_rel
Discrete_Value_Groups
Discrete_ValuesQuestions
Question_Category_Relations
Derive_cde.sql
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caDSR mapping to Oracle ClinicalcaDSR mapping to Oracle Clinical
Input CDE field Column in NCI_CDE table Used in OC DVG Tables Used in OC Questions table Other
DVG = discrete_value_groups Q = questions
DV = discrete_values
De Preferred Name PREFERRED_NAME Q.nameVd Preferred Name VD_PREFERRED_NAME DVG.nameDe Doc Text QUESTION Q.default_prompt
Dtl Name DATA_TYPEDVG.dvg_sub_type_code (decoded)
Q.que_sub_type_code and Q.question_data_type_code (decoded)
Vd Type Flag ENUMERATED
Not stored - but used to identify DVGs ('E' - dvg, 'N' = question)
Max Length Num MAXIMUM_LENGTH DVG.maximum_value_lengthQ.length (if dtype = NUMBER length set to 10)
Decimal Place DECIMAL_PLACES Q.decimal_placesVd Long Name VD_LONG_NAME DVG.descriptionValue VALUE DV.discrete_value_value
Short Meaning MEANINGDV.long_label_description (first 200 chars only)
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caDSR mapping to Oracle Clinical (2)caDSR mapping to Oracle Clinical (2)
High Value Num HIGH_VALUE Q.upper_boundLow Value Num LOW_VALUE Q.lower_boundDe Preferred Definition PREFERRED_DEFINITION Q.intent (first 200 chars), and
Q.sas_label (first 40 chars)
De Comments COMMENTS Not stored
De Id Seq CDE_ID Q.status_comment_textContext CONTEXT
DERIVED_NAME Q.Name
created w/ derive.sql as translation and substr of PREFERRED_NAME
VD_DERIVED_NAME DVG.Name
created w/ derive.sql as translation and substr of VD_PREFERRED_NAME
SAS_NAME Q.sas_namecreated w/ derive.sql as 'A<sequence numb>A'
Input CDE field Column in NCI_CDE table Used in OC DVG Tables Used in OC Questions table Other
DVG = discrete_value_groups Q = questions
DV = discrete_values
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Review, Modify and Activate DVGReview, Modify and Activate DVG
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Refine Question Definitions as neededRefine Question Definitions as needed
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C3D VisionC3D Vision
OracleClinicalRepository
Global Library
Elements
RDC – Internet Explorer
CRF EntryDiscrepancy Mngt
MonitorsCTMSCDUS
Discoverer
Data Entry ValidationClinical reportingQuality Assurance
Clinical – Internet Explorer
Study TemplateStudy Instantiation
Consolidated Clinical Data Warehouse
TemplatesStudies
Legacy ClinicalData Repositories•netTrials•PDMS•Etc..
Map to studyBatch Data Load
TransformationNormalizationCDEification
ExtractFormat
Current ClinicalData Repositories•MIS Labs (CDW)•Navy Labs (HL7)•netTrials•PDMS•Etc..
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Remote Data Capture (RDC) MatrixRemote Data Capture (RDC) Matrix
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RDC – Enrollment CRFRDC – Enrollment CRF
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Enrollment CRF CDEsEnrollment CRF CDEs
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Discoverer Enrollment Extract ViewDiscoverer Enrollment Extract View
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Discoverer Theradex EN File ViewDiscoverer Theradex EN File View