Clinical Research Administration: Protocols and Ethics

Description

Welcome to Clinical Research Administration: Protocols and Ethics. In this course, you'll learn:

1. Introduction to Clinical Research Administration:

   • Overview of the clinical research landscape
   • Historical perspective and evolution of clinical trials
   • Key stakeholders and their roles in clinical research

2. Clinical Trial Design and Planning:

   • Principles of study design
   • Protocol development and optimization
   • Budgeting and resource allocation
   • Planning for participant recruitment and retention

3. Ethics and Regulatory Compliance:

   • Understanding ethical principles in clinical research
   • Overview of regulatory requirements and guidelines
   • Importance of informed consent
   • Addressing ethical challenges in research

4. Institutional Review Boards (IRBs) and Ethics Committees:

   • Role and functions of IRBs and Ethics Committees
   • IRB submission and review process
   • Ethical review and oversight

5. Data Management and Recordkeeping:

   • Best practices in data collection and management
   • Ensuring data integrity and quality
   • Electronic data capture (EDC) systems
   • Regulatory requirements for data storage and retention

6. Safety Reporting and Adverse Events:

   • Adverse event reporting and monitoring
   • Safety reporting to regulatory authorities
   • Developing strategies for participant safety

7. Clinical Trial Monitoring and Auditing:

   • Importance of monitoring and auditing
   • Roles and responsibilities of monitors and auditors
   • Implementing effective monitoring and auditing strategies

8. Study Site Management and Quality Control:

   • Site selection and initiation
   • Site management and quality assurance
   • Ensuring compliance at study sites

9. Data Analysis and Reporting:

   • Basics of statistical analysis in clinical research
   • Interpreting and reporting study results
   • Ensuring data integrity in analysis and reporting

10. The Future of Clinical Research:

    • Emerging trends in clinical research
    • Innovation in study design and conduct
    • Technological advancements in data collection and analysis