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Advanced Clinical Trial Management

Clinical trials are essential for advancing medical knowledge and improving patient care. This course provides a comprehensive understanding of the clinical trial process, from study design and regulatory compliance to data management and ethical considerations. Participants will explore best practices for conducting successful trials, ensuring patient safety, and maintaining data integrity.Through interactive case studies and real-world examples, learners will gain insights into trial phases, sponsor-investigator responsibilities, and risk management strategies. This course is designed for professionals seeking to enhance their expertise in clinical research and trial management.
Course: 8 Weeks

Certificate

Course Brochure

Course Syllabus

Module 1: Introduction to Clinical Trials

  • Overview of Clinical Research
  • Phases of Clinical Trials
  • Key Stakeholders in Clinical Trials

Module 2: Regulatory & Ethical Considerations

  • Good Clinical Practice (GCP) Guidelines
  • Institutional Review Boards (IRB) & Ethics Committees
  • Informed Consent Process

Module 3: Study Design & Protocol Development

  • Types of Clinical Trial Designs
  • Developing a Clinical Trial Protocol
  • Patient Recruitment & Retention Strategies

Module 4: Trial Management & Monitoring

  • Roles & Responsibilities of a Clinical Trial Manager
  • Site Selection & Initiation
  • Monitoring & Auditing Clinical Trials

Module 5: Data Management & Statistical Analysis

  • Collecting & Managing Clinical Data
  • Ensuring Data Quality & Integrity
  • Basics of Biostatistics in Clinical Research

Module 6: Risk & Compliance Management

  • Identifying & Managing Risks in Clinical Trials
  • Handling Protocol Deviations & Adverse Events
  • Regulatory Reporting Requirements

Module 7: Final Study Reports & Publication

  • Writing Clinical Study Reports
  • Submission to Regulatory Authorities
  • Ethical Considerations in Publishing Trial Results

Module 8: Career Opportunities & Industry Trends

  • Job Roles in Clinical Research
  • Emerging Trends & Future of Clinical Trials
  • Certifications & Further Learning Opportunities

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