BioRDFClinical Trial Workflow

December 12, 2006Bill Dyer

bill.dyer@oracle.com

FOI Public DataFOI Public DataFOI Public Data

Lab DataExternal Lab

DataExternal LabExternal Lab

DataData

Contract Research

Organization

Contract Contract ResearchResearch

OrganizationOrganization

RegulatoryAgenciesRegulatoryRegulatoryAgenciesAgencies

BiomedicalCompany

BiomedicalBiomedicalCompanyCompany

PharmaceuticalCompany

PharmaceuticalPharmaceuticalCompany Company

Sponsor

Clinical Trials

Sponsor

Clinical Trials

Clinical Trial Data Flow

HospitalPrivate DataPrivate DataPrivate Data

Hospital and PCP Patient Data

Hospital and Hospital and PCP Patient DataPCP Patient Data

AcademicResearch Center

AcademicAcademicResearch CenterResearch Center

FDAFDAFDA

NIHNIHNIH

InvestigatorStudy SitesInvestigatorInvestigatorStudy SitesStudy Sites

2

Clinical Trial Data Flow (2)

Sponsor

Academic Research

Organization

Contract Research

Organization

Investigators

FDA NIH

Hospital

Laboratory

Workflow Of CDM

StudyStudyInitiationInitiation

PlanningPlanning

Protocol, CRF

Study Study ProtocolProtocol& CRF & CRF FinalizedFinalized

Prepare Prepare Study DatabaseStudy Database

ReportingPrograms

DataDataCorrection /Correction /

Discrepancy Mgt.Discrepancy Mgt.

LockLockDatabasesDatabases

QuicklyQuicklyQualityQualityControlControl

Data EntryData EntryBatch Data Batch Data

LoadingLoading

First First PatientPatientEnrolledEnrolled

Locking &Locking &FreezingFreezing

Last PatientLast PatientLast ObservationLast Observation

DataDataExtractionExtraction

AnalysisReporting

automatically into SAS

DraftDraftFinalFinalStudyStudyReportReport

Data Capture and Management

EntryEntryPass 1Pass 1

DiscrepanciesOptionalOptionalEntryEntry

Pass 2Pass 2

CRFCRFLoginLogin

SIMPLE SIMPLE VALIDATIONVALIDATIONFAILURESFAILURES

RangeRangeListListData TypeData TypeMandatoryMandatoryLengthLength

Manual Manual Discrepancies/Discrepancies/Operator CommentOperator Comment

PatientData

CRF Tracking

Audit Trail

Study PatientVITAL SIGNS

Blood Pressure ___ / ___Temperature ___Pulse Rate ___Respiratory Rate <80<80

Visit

Study PatientVITAL SIGNS

Blood Pressure ___ / ___Temperature ___Pulse Rate ___Respiratory Rate ___

Visit

Study PatientVisit

DifferencesDifferencesto Pass 1to Pass 1

Investigator Investigator CommentsComments

UNKUNK

Discrepancy Resolution

DE MgrDE MgrReviewReview

CDCCDCReviewReview

SimpleSimpleValidationValidationFailuresFailures ManualManual

DiscrepencyDiscrepency

CRACRAReviewReview

CollectedCollectedDataData

VALIDATIONPROCEDURESFAILURES

If... Then...Look-UpTrend AnalysisThesaurus

AcceptedAcceptedDataData

SYNCHRONIZEDSYNCHRONIZEDhothot--li

nklin

k

DCF

DiscrepenciesDiscrepencies

Investigator: Site:Patient:CRF:Discrep. Data:Discrep. Review:

Patient Data