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Practical Guide to Clinical Data Management

BuchGebunden
250 Seiten
Englisch
CRC Presserschienen am03.07.20244th edition
A Practical Guide to Clinical Data Management, Fourth Edition provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks.mehr
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EUR151,50
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Produkt

KlappentextA Practical Guide to Clinical Data Management, Fourth Edition provides a comprehensive overview of the tasks involved in clinical data management and the computer systems used to perform those tasks.
Details
ISBN/GTIN978-1-032-49558-3
ProduktartBuch
EinbandartGebunden
FormatGenäht
Verlag
Erscheinungsjahr2024
Erscheinungsdatum03.07.2024
Auflage4th edition
Seiten250 Seiten
SpracheEnglisch
MasseBreite 156 mm, Höhe 234 mm, Dicke 16 mm
Gewicht553 g
Artikel-Nr.61443257
Rubriken
GenreMedizin

Inhalt/Kritik

Inhaltsverzeichnis
PrefaceAcknowledgementsCommon AcronymsIntroduction to Clinical TrialsTesting in HumansClinical Trial ProtocolsClinical Trial ProcessThe Importance of Clinical Data ManagementRegulations, Guidance, and ICH E6 (GCP)Part I: Study StartupChapter 1: The Data Management PlanPurpose of Data Management PlansContents of the DMPInitiating the DMPApproving the DMPRevising the DMPUsing DMPs with CROsThe Value of Data Management PlansData Quality and DMPsSOPs for DMPsChapter 2: CRF Design ConsiderationsPrimary Goals of CRF DesignCollecting Required Data: Visits, Forms, & FieldsCollecting Analyzable DataProtocol ComplianceCRFs Linked to Non-CRF DataReuse and Refine CRF ModulesData Quality through CRF DesignSOPs on CRF DesignChapter 3: Selecting Edit ChecksIdentifying Possible Edit ChecksFocus on Critical VariablesData Validation/Edit Check SpecificationsUpdating Data Validation SpecificationsData Quality through Data ValidationSOPs for Data Validation ChecksChapter 4: EDC Study Build and ReleaseeCRF BuildData Validation/Edit Check ProgrammingEDC Study TestingRelease to ProductionChange ControlData Quality for eCRFs and Edit ChecksSOPs on EDC BuildChapter 5: Planning for Blinded StudiesBackground on BlindingMaintaining the BlindAccidental UnblindingUnblinded Study Team MembersBlinding Impacts Data QualitySOPs and Study Plans for BlindingChapter 6: Patient Reported OutcomesBackground to Patient Reported OutcomesLicensing PRO QuestionnairesConsiderations for Electronic CollectionConsideration for Paper InstrumentsProtocol ComplianceBudgeting Time and MoneyQuality Assurance for ePROSOPs and Study Plans for ePROPart II: Study ConductChapter 7: Overseeing eCRF Data EntryTracking Participants EnrolledForms Entered vs Forms ExpectedTracking Investigator SignaturesMonitoring Data Entry Benefits Data QualitySOPs and Plans for Overseeing eCRF Data CollectionChapter 8: Managing QueriesSystem QueriesManual QueriesTracking Open QueriesQuality Control for QueriesUsing Queries to Improve QualitySOPs and Plans for Managing QueriesChapter 9: Collecting Adverse Event DataCollecting AEs and SAEsAdverse Event FormsStoring and Cleaning AE DataCoding Adverse Event TermsReconciling Serious Adverse EventsCoding and Reconciliation ApprovalsData Quality for AEsSOPs and Study Plans for AE DataChapter 10: Managing Lab DataData Management for Lab DataLab Test NamesStoring UnitsLab Reference RangesLaboratory IdentificationCentral LabsUsing Specialty LabsData Quality for Lab ResultsSOPs and Study Plans for Processing Lab DataChapter 11: Receiving Non-CRF DataReceiving Electronic Files from a VendorCleaning Non-CRF DataManaging Blinded DataData Quality for External DataSOPs and Study Plans for Non-CRF DataChapter 12: Data ReviewEdit Checks vs Data ReviewData Review PlanPerforming Data ReviewPlanning for Manual QueriesData Quality and Manual Data ReviewsSOPs and Study Plans for Data ReviewChapter 13: Risk-Based Quality ManagementBackgroundA Structure for Risk-Based Quality ManagementCentralized MonitoringWorking with Clinical OperationsRBQM is Quality AssuranceSOPs and Study Plans for RBQMChapter 14: Managing EDC ChangesChange Control for StudieseCRF ChangesEdit Check ChangesOther Study ChangesTesting and ApprovalImpact on Investigator SignaturesChanges Associated with a Protocol AmendmentMaintaining Data Quality during EDC Study ChangesSOPs for EDC ChangesPart III: Study LockChapter 15: Study LockCore Requirements for Study LockFinal Study LockInterim Study LockData Extract Plans or SpecificationsSoft LockTime to Study Database LockFinal Data QualitySOPs and Study Plans for Study LocksChapter 16: After Study LockPost-Lock ActivitiesUnlocking EDC StudiesData Quality and TMF QualitySOPs and Sutdy Plans for Post-Lock and UnlockPart IV: Necessary InfrastructureChapter 17: SOPs for CDMWhat Is an SOP?SOPs for Data ManagementCreating SOPsComplying with SOPsSOP on SOPsQuality Assurance through SOP RevisionsChapter 18: CDM and the TMFTMF Reference ModelReviewing the Study Reference ModelSubmitting to the TMFTMF QCSupporting Documents, Email, and NTFsLiving with the TMFChapter 19: TrainingMinimum Required TrainingTraining MatricesHow to TrainTraining RecordsExperience and EducationAllotting Time for TrainingSOPs on TrainingChapter 20: User ManagementAccount ManagementAccess Control through RolesTaking Security SeriouslySOPs and Guidelines for AccountsChapter 21: Developing and Using StandardsThe Goal and Purpose of Standards\Industry StandardsWhere to StartStandards Team GovernanceUsing StandardsSOPs for StandardsChapter 22: Working with Service ProvidersData Management CROsThe CRO MythQualifying CROsDefining ResponsibilitiesOversight MetricsOversight During the TrialResourcingEDC Vendors as CROsFunctional Service ProvidersBenefiting from CROsSOPs for working with CROsPart V: Using Computerized SystemsChapter 23: Data IntegrityWhat is Data Integrity?Integrity in the Data LifecycleDemonstrating Integrity in TransfersApplying Risk AssessmentsChapter 24: Data in EDC SystemsControl of Data: HostingData Entry by the Sponsor or CRONeed for Data RepositoriesChapter 25: Choosing Vendor SystemsDefining Business NeedsInitial Data GatheringExtended Demos and PilotsAdditional ConsiderationsWhat is Missing?Qualifying a VendorPreparing for ImplementationChapter 26: Implementation PlanningOverview and Related PlansEssential PreparationValidationIntegration and ExtensionsMigration of Legacy DataBenefiting from PilotsAssessing SOPs and Other DocumentsPreparation for ProductionSuccessful ImplementationChapter 27: System ValidationWhat Is System Validation?Systems that Require ValidationValidation for Hosted SystemsValidation PlanValidation TestingValidation ReportChange ControlRequirements and BenefitsChapter 28: Migrating and Archiving DataRegulatory ExpectationsWhen to MigrateEDC MigrationsComplex MigrationsMigration by Re-EntryAudit Trails in MigrationsArchiving and DecommissioningMigration and Archive PlansData Integrity for Migrations and ArchivesChapter 29: EDC Study RebuildsCircumstances Leading to RebuildseCRF and Edit Check RebuildMoving DataInvestigator SignaturesIntegrated Systems Site ImpactDocumentationAppendix A: Data Management Plan TemplateAppendix B: Data Extract Plan TemplateAppendix C: System Implementation OutlineIndexmehr

Autor

Susanne Prokscha has been involved in clinical data management (CDM) processes and technologies since the mid-1980's. She has worked both as a consultant and directly for companies large and small, gaining experience with a wide range of studies and a variety of CDM systems. Since 2007, Susanne has been focusing on standard operating procedure (SOP) development, document management, and training plans for CDM and for other functions in clinical research and development.