BIOT 215 - Clinical Trials

OR

Program Advisor Approval.

PROGRAM: Biotechnology
CREDIT HOURS MIN: 3
LECTURE HOURS MIN: 3
TOTAL CONTACT HOURS MIN: 48
DATE OF LAST REVISION: Fall 2025

This course provides a basic introduction to clinical trial processes to include governing regulations and standards as applied to trial design, conduct, records, and documentation. The course also covers the roles of clinical trials in medicinal product development processes.

MAJOR COURSE LEARNING OBJECTIVES: Upon successful completion of this course, the student will be expected to:

1. Demonstrate knowledge and evaluation of relevant Title 21 Code of Federal Regulations (CFR) to clinical trials.
2. Describe the clinical trial processes used to gain approval for drugs, medical devices, and biologics as they relate to relevant regulations, application, submission, marketing, and post-marketing surveillance.
3. Demonstrate an understanding of the most recent Food and Drug Administration (FDA) Guidance to Industry E6 Good Clinical Practice (GCP) and how it relates to International Council for Harmonization (ICH) guidelines as well as current Good Manufacturing Practice (cGMP) standards.
4. Demonstrate familiarity with authoritative and relevant third-party websites including FDA.gov, NIH.gov, ClinicalTrials.gov, ICH.org, ISO.org, and/or ANSI.org.
5. Describe the contents of an investigator’s drug brochure, pharmacovigilance reports, and compliance reports.
6. Analyze the subjective and interpretive aspects of regulations and guidance documents.
7. Describe how International Organization for Standardization (ISO) guidelines apply to Good Clinical Practice (GCP), risk management, and quality systems for medical device clinical trials.
8. Apply information from the FDA Feasibility and First-in-Human (FIH) guidance documentation for medical devices.
9. Demonstrate knowledge of essential study documents as prescribed by regulations and guidance documents that are required before trial initiation, during trial conduct, and at study close-out.
10. Apply the fundamental concepts of premarket regulatory activities for medical devices in the United States.
11. Demonstrate the ability to understand and discuss the ethics of clinical trials, including historical background, current issues, and regulations that govern institutional review boards (IRBs).
12. Apply regulations with respect to adverse event (AE) reporting regulations.
13. Describe clinical trial site activities.
14. Describe how data is managed at the clinical site.

• History and purpose of clinical trial regulations 
• ICH-GCPs and FDA CFRs governing clinical trials
• FDA.gov and other regulatory/guidance websites and databases
• Required clinical trial documentation for sites and sponsors
• Protocol development and analysis
• Protocol site feasibility
• ISO standards for medical devices, including ISO 14155, ISO 14971, and ISO 13485
• FDA IND/IDE and FIH guidance
• Informed consent process
• Institutional Review Boards
• Adverse Events
• Monitoring of clinical trials
• Drug, medical device, and biologics development processes
• The roles and responsibilities of principle investigators and study coordinators
• Study activities
• Management of study drugs and medical devices
• Managing clinical trial data
• Overview of medical device development
• Case studies of medical device clinical trials