Clinical Trails and Clinical Data ManagementPhase trails: preclinical1,2,3 and 4Drug discovery and developmentICH GCPComputer system validation21 CFR 11CRF designingPharmacokineticsPharmacovigilanceClinical data management processCDISC introductionCTM systemsData management plan

Sub ChapterGeneral abbreviated termsIntroduction to clinical trailsResponsibilities of CRAActivities of CRA in houseCRA monitoringClinical trail monitoringResponsibilities of PIIRBInformed consent formICH historyGPC guidelines

Sub ChapterFDA historyFDA guidelinesIND,NDA reviewsClinical research study documentCRF reviews and sample CRFsCRF data submissionCRF receivingIntroduction to SAS in CDM

Components of SAS Different data typesBase/SASSAS/STATSAS/GraphSAS/ACCESSSAS proceduresSAS ProceduresSAS MacrosSAS (working with sql)

Open clinicalData base designProtocol planningCRF Data entryData managementStudy planningStudy designOracle clinical (overview)

L/O/G/O

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