This course provides a review of the clinical trial process. Starting with the history of regulatory oversight, it reviews each of the steps necessary to develop, initiate and manage a clinical trial according to Good Clinical Practices (GCPs). It provides insight into the roles of the individual members of the clinical research team, and provides a practical approach to preventing the pitfalls associated with many clinical trials.

This course is different from many other courses in that its perspective is from that of the site based investigator rather than the sponsor. It recognizes that not all clinical trials are conducted under the auspices of a pharmaceutical company and provides the sponsor-investigator as well as the site based clinical research team the information necessary to independently conduct a clinical trial. Particular emphasis is given to the academic based clinical research team when appropriate.

This course provides an excellent tool for the training and education of all members of the clinical research team to insure their knowledge and understanding of the clinical research process and GCPs. It is also a helpful tool for sponsors, whether corporate or academic, since it can help verify the required GCP training of investigators and other team members.

You should expect to spend approximately 13 hours of study time to complete the course.

• Interpret FDA regulations and ICH guidelines pertaining to GCPs
• Apply GCP regulations and guidelines to your process around informed consent, adverse event reporting, records and reports, and drug accountability
• Describe the IRB/EC responsibilities for ensuring the ethical conduct of clinical research
• Identify the sponsor's responsibilities for monitoring study sites
• Explain the FDA inspection process and identify areas of common deficiencies

• Regulatory Environment in the US
• International GCP Regulations
• Sponsor Obligations
• Protocol Development and Content
• Investigator Responsibilities
• Investigational Review Boards (IRB) /Ethics Committees (EC)
• Adverse Event Reporting
• Monitoring of Clinical Studies
• Data Management
• Clinical Quality Assurance, and
• FDA Inspections