CHHS Student Success Center

Learning Outcomes: B.S. Clinical Research

Program Objectives

At the time of graduation students should be able to:

  1. Discuss scientific concepts related to the design and analysis of clinical trials for biopharmaceutical and medical device product development.
  2. Demonstrate an understanding of ethical issues, protection of human subjects, and evaluation of safety in the conduct of clinical trials.
  3. Explain the fundamentals of development and regulation of drugs, devices, and biologicals.
  4. Discuss clinical study operations including study management, compliance with Good Clinical Practice (GCP) guidelines, safety management (adverse event identification and reporting, post marketing safety surveillance, and pharmacovigilance), and handling of investigational product.
  5. Describe how clinical study data are collected and managed during a clinical trial, including source data, data entry, queries, quality control, and correction and the concept of a locked database.
  6. Discuss principles and practice of leadership and professionalism in clinical research including teamwork skills necessary for conducting a clinical trial.