Course Description
Fundamentals of the clinical trials environment, study design and management. Emphasis on the initiation, administration, coordination, and management of clinical research studies for the development of new drugs, biologics and other clinical products.
Athena Title
Clinical Trial Design and Mgmt
Equivalent Courses
Not open to students with credit in PHAR 6200
Non-Traditional Format
This course will be taught 95% or more online.
Prerequisite
Permission of department
Pre or Corequisite
[(PHAR 6010 or PHAR 6010E) and (PHAR 6020 or PHAR 6020E)] or permission of department
Semester Course Offered
Offered every year.
Grading System
A - F (Traditional)
Course Objectives
• Identify the roles and responsibilities of investigators, sponsors, and subjects of clinical research • Compare and contrast the regulations and Good Clinical Practices (GCP) governing clinical research • Describe the various objectives of a good clinical study design • Apply the principles of designing a clinical study that fulfills research objectives • Apply the principles of quality assurance in clinical trial management
Topical Outline
Clinical trial design limitations, problems, and solutions; Good Clinical Practices and Quality Assurance; Integrated model systems and simulated trials; Optimal clinical trial set-up and follow through; Designs for domestic and international clinical trials; Critical review and analysis of clinical data process; Effective project management through each phase of the clinical trial
Syllabus
Public CV