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
Top Related