Dec 21, 2024  
2023-2024 Graduate Bulletin 
    
Catalog Navigation
  Bulletin Home
  About Austin Peay State University
  Academic Calendar
  APSU Policies
  College of Graduate Studies Admissions Guidelines
  College of Graduate Studies Programs and Degrees
  Sample Degree Plans
  University Wide Degree Requirements
  University Academic Regulations
  Graduate Research Requirements
  Graduate Assistantships
  Graduate Course Descriptions
  Graduate Fees and Expenses
  Student Financial Aid, Scholarships & Veterans Education Benefits
  Regulations for Residency
  Distance Education
  Honors and Awards
  Administration and Faculty
  Centers of Excellence
  Student Life
  Student Services
  Student Right to Know
  APSU Telephone and Web Directory
  Campus Map
  Study Abroad and Exchange Programs
HELP
2023-2024 Graduate Bulletin [ARCHIVED CATALOG]

STAT 5300 - Clinical Trials and Regulatory Requirements/Guidelines

Credit Hours 3
Prerequisite: Admission to the MS or PSM in Computer Science and Quantitative Methods or graduate certificate in Biometrics and clinical trials or Instructor permission
Description: This course prepares students for data analysis careers in the Pharmaceutical, Biotechnology or Medical Device Industry.  It addresses the ability to set goals and objectives of Clinical Trials, Design a Clinical Trial proposal and get regulatory and Institutional Review Board approvals as well as focuses on introduction to clinical trials, Protocol Development, Selection of an appropriate experimental design, Methods of randomization, Sample size determination, Appropriate methods of analysis; Interim monitoring; and Ethical issues, the roles and responsibilities of Regulatory Specialist in the Pharmaceutical pharmaceutical and related industries; Overview of International Conference on Harmonization and Good Clinical Practice guidance, FDA regulatory pathways, and Interacting with regulatory agencies.