Curriculum

This course provides an introduction to good clinical practice (GCP) in clinical research according to FDA regulations and International Conference on Harmonization (ICH) guidelines.

Topics include:

• Conducting clinical trials in accordance with GCP
• Regulations established by state, federal, and international regulatory bodies
• The roles and responsibilities of investigators, sponsors, monitors, and auditors

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

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

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 and 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.

The purpose of this course is to introduce you to the process and procedures of monitoring a clinical trial as a clinical research associate working for a pharmaceutical or device manufacturer (known as the sponsor).

• The course is focused on trials conducted under U.S. FDA applications (INDs and IDEs).
• The process of monitoring begins with creating a risk-based monitoring plan and progresses through selecting qualified investigators, executing the assessments defined in the monitoring plan, changing the plan and actions when problems and issues are identified, and closing the sites as their study participation concludes.

Sponsors follow Standard Operating Procedures for monitoring clinical trials, which are based on the FDA regulations as found in 21 CFR, Parts 11,50, 54, 56, 312 and 812 and in guidance documents, such as the International Conference on Harmonization (ICH) Guidelines for Good Clinical Practice (GCP) E6 and Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring.

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 clinical trials budgets
• Managing timelines
• Leading and motivating effective teams