Overview

A warm welcome to the Clinical SAS: Mastering Clinical Data Management and Analysis with SAS course by Uplatz.Clinical SAS is a software suite developed by SAS Institute, a leading provider of analytics and business intelligence solutions. SAS Clinical is specifically designed to support the needs of clinical research organizations and pharmaceutical companies in managing, analysing, and reporting clinical trial data.Some key features of Clinical SAS include:Data Management: SAS Clinical enables users to efficiently manage and integrate clinical trial data from multiple sources, including electronic health records, case report forms, laboratory data, and patient diaries.Statistical Analysis: The software provides a comprehensive set of statistical tools for analysing clinical trial data, including descriptive statistics, hypothesis testing, regression analysis, survival analysis, and more.Reporting and Visualization: SAS Clinical offers powerful reporting and visualization capabilities, allowing users to create customized reports, tables, graphs, and dashboards to communicate findings and insights effectively.Regulatory Compliance: SAS Clinical is designed to meet regulatory requirements and standards such as FDA's 21 CFR Part 11, ensuring data integrity, security, and compliance with industry regulations.Integration with Other Systems: SAS Clinical can be integrated with other systems and platforms commonly used in clinical research, such as electronic data capture (EDC) systems, clinical trial management systems (CTMS), and data warehouses.SAS Clinical provides a robust and flexible platform for managing and analysing clinical trial data, helping researchers and organizations streamline the drug development process, make informed decisions, and accelerate time to market for new therapies.Clinical SAS - Course CurriculumSAS Clinical Research OverviewHistorical and Ethical background of Clinical Research and ICH-GCP GuidelinesEssential Documents in Clinical ResearchDrug DevelopmentClinical Trial Process and RolesClinical Trial DesignClinical Trial MonitoringGlossary of Clinical Research TermsResponsibilities of SponsorSite Selection and Responsibilities of Investigator and CRCQA and QC Audit and InspectionNon-Compliance, Fraud and Misconduct21 CFR part 11Protocol UnderstandingClinical Data ManagementProtocol AssignmentCRF Design and FormatCRF Design and Format demoClinical Data StandardsCDM Study Start UpCDM - EDC Setup ConceptCDM - EDC Study Conduct ConceptCDM - EDC Study Conduct Discrepancy ManagementCDM - Discrepancy ManagementData Management PlanProject Management for Data ManagerVendor Selection and ManagementEdit Check Design PrinciplesEDC Study CloseoutCDM Study CloseoutCRF Completion GuidelinesDatabase Validation and ProgrammingLaboratory Data HandlingExternal Data TransferPatient Reported OutcomeInvestigator MeetingMetrics in CDMAssuring Data QualityMeasuring Data QualitySafety Data ManagementSafety Data ReconciliationMedical CodingClinical Data ArchivingData Entry and ProcessingRole and Responsibilities of CDMMedical Device TrialsClinical Research Q and AClinical Data Management Q and AClinical Research CDM Fundamental Q and AWorking with CROs and SOPsCDISC - part 1CDISC - part 2

Skills

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