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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