Research Management

Catalog description

This course addresses operational issues that arise in the conduct of a clinical research project. Topics include administration (human resources, project management, budget development and management), data management systems (databases, case report forms, data acquisition, quality assurance and quality control (QA/QC), monitoring and auditing), regulation (Investigational New Drug [IND]) applications, good clinical practice (GCP), and the Health Insurance Portability and Accountability Act (HIPAA), and sponsorship (sources, sponsor motivations, identification of sponsors). Prerequisite: None. Credits: 2.