Clinical Research Administration: Protocols and Ethics

Introduction to Clinical Research Administration:Overview of the clinical research landscapeHistorical perspective and evolution of clinical trialsKey stakeholders and their roles in clinical research

Clinical Trial Design and Planning:Principles of study designProtocol development and optimizationBudgeting and resource allocationPlanning for participant recruitment and retention

Ethics and Regulatory Compliance:Understanding ethical principles in clinical researchOverview of regulatory requirements and guidelinesImportance of informed consentAddressing ethical challenges in research

Institutional Review Boards (IRBs) and Ethics Committees:Role and functions of IRBs and Ethics CommitteesIRB submission and review processEthical review and oversight

Data Management and Recordkeeping:Best practices in data collection and managementEnsuring data integrity and qualityElectronic data capture (EDC) systemsRegulatory requirements for data storage and retention

Safety Reporting and Adverse Events:Adverse event reporting and monitoringSafety reporting to regulatory authoritiesDeveloping strategies for participant safety

Clinical Trial Monitoring and Auditing:Importance of monitoring and auditingRoles and responsibilities of monitors and auditorsImplementing effective monitoring and auditing strategies

Study Site Management and Quality Control:Site selection and initiationSite management and quality assuranceEnsuring compliance at study sites

Data Analysis and Reporting:Basics of statistical analysis in clinical researchInterpreting and reporting study resultsEnsuring data integrity in analysis and reporting

The Future of Clinical Research:Emerging trends in clinical researchInnovation in study design and conductTechnological advancements in data collection and analysis