Essentials of Clinical Research

Do you know the importance of clinical research? Every medication, apparatus, instrument, diagnostic procedure, technique and technological advancement employed in modern medicine was tried on volunteers in clinical research studies before. This course begins with the clinical research process for achieving accurate and valid results before delving into regulatory requirements for clinical research to protect participants. We cover clinical trials and good clinical practice (GCP) for ethical and responsible research, including data management and quality assurance.

The course then outlines the steps for the clinical trial process with types of clinical trials for advancing medical care and new treatment. We illustrate how to design a clinical trial protocol for a successful study with strategies for ensuring clinical trial protocol compliance. Explore the primary ethical considerations and guidelines for ethical and responsible research with ethical issues in publication and authorship to maintain the research integrity and reliability.

Finally, the course covers the purpose, type, benefits and challenges of clinical trial monitoring and auditing. We will show examples of documents for clinical trial auditing, including how to implement GCP guidelines. We discuss clinical trial reporting requirements and the basics of biostatistics with how to apply statistical techniques to clinical research. We explain clinical research project management, risk-based monitoring and plan work with different clinical research vendors.