BTEC 3410 - Experimental Design & Analysis: Product Registration and Clinical Trials

3 Class Hours 0 Laboratory Hours 3 Credit Hours
Prerequisite: Grade of “C” or better in BTEC 3400 and STAT 3125.
This course provides students with an understanding of the methods used in collecting, organizing and managing data as well as an understanding of the concepts involved in Good Manufacturing Practices as related to the biotechnology industry. Issues involving study design, randomization schemes and sample size will be discussed. Operational issues in clinical trials, recruitment of participants, data collection, quality control and data monitoring are also learned. A clinical trial protocol will be written and reviewed as for regulatory submission.