Curriculum & Courses

CTMI 30109 | Non-credit | Instructor: Lauren Wall

This course introduces good clinical practice (GCP) in clinical research according to Food and Drug Administration (FDA) regulations and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines. Topics include conducting clinical trials in accordance with GCP; regulations established by state, federal, and international regulatory bodies; and the roles and responsibilities of investigators, sponsors, monitors, and auditors.

CTMI 30110 | Non-credit | Instructor: Amanda Spratt

This course provides an overview of the drug development and clinical trials processes. Topics include the discovery of new molecules, how discoveries become drugs or devices, the purpose of clinical and pharmaceutical research and development, the economics of drug development, cost-benefit analyses in clinical development, phase I–IV clinical trials, and an introduction to the special problems of each phase.

CTMI 30113 | 50 units | Instructor: Lauren Wall

This course introduces students to the processes and procedures of monitoring a clinical trial from the perspective of the sponsor or contract research organization from the site-initiation visit to the closing out of a clinical study.

CTMI 30111 | 50 units | Instructor: Melvin Munsaka

This course introduces basic statistical concepts, such as hypothesis testing, P values, and power determination. Other concepts with relevance to clinical research design and monitoring—such as the importance of randomization and randomization procedures, stratification, crossover designs, nonrandomized concurrent control studies, and the use of historical controls—will also be introduced.

CTMI 30114 | 50 units | Instructor: Imran Khan

This course focuses on advanced strategic, operational, and project management topics in clinical research with an emphasis on increasing efficiency and quality at all levels of the process. Topics include allocating staff and resources effectively; assessing financial and regulatory implications from a business perspective; developing, negotiating, and managing comprehensive budgets; managing timelines; and leading and motivating effective teams.

CTMI 30112 | 50 units | Instructor: Sara Moellering

This course covers the process of coordinating and managing a clinical study from the perspective of the study site. Students will learn the essentials of coordinating and managing the day-to-day operations of a clinical research study, from planning site logistics to constructing timelines for the study-initiation visit to closing out a study. The course will focus on the operational, interpersonal, and data-management aspects of the process. It will include an experiential component with rotations through operations, monitoring, regulatory processes, and project work.  The rotations will bring together the concepts taught in each course and provide opportunities for real-world application of the knowledge and skills gained throughout the quarter.