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.
A “C” (2.00) or better is required in each required CLR core course in order to progress. A cumulative grade point average of 2.00 or better is required for graduation.
A “C” (2.0) or better is required in all required non-CLR courses in order to apply to/progress in the program.
All required CLR 300 level courses must be taken prior to enrollment in internship (CLR 496 ).
Many of the required courses are sequential, have prerequisites, and may be offered only once a year; therefore, it is imperative that students consult with the academic advisor and follow the prescribed program of study. Students are also expected to complete the university studies requirements during the freshman and sophomore years because of the rigor and concentration of lab courses and the internship in the major. The recommended 15-17 semester hour course load each semester is necessary to complete the program in four academic years. In addition to the university studies and required prerequisite courses, elective credits are also included in the 124 hours required for graduation. To qualify for the Bachelor of Science in Clinical Research, 25% of the total semester hours must be taken in residence at UNCW.