The conduct of clinical research requires effective working relationships between the study sites that execute clinical trials and the sponsors that design the trials and provide product for testing. This course offers practical insight into the clinical research process from the viewpoint of the study site. Lectures and class exercises explore the roles, responsibilities, interactions, and concerns of study site personnel and highlight important differences in perspective between clinical study sites and industry sponsors. Course content applies to all study sites, including academic medical centers, community hospitals, rural clinics, physician private practices, hospital networks, and Phase 1 units. Whether you work at a study site, for a sponsor, or are interested in opportunities at these organizations, this course will provide you with a deeper understanding of the study site's role in clinical research.

Topics include:

• Types of clinical trials, sponsors and study sites
• The study site team's roles and responsibilities
• The clinical research team and the study site's relationship with each player
• Study site and sponsor expectations
• GCPs and essential documents for clinical trials
• Study start-up activities
• Subject recruitment, screening, informed consent and enrollment
• Case report forms and source data/documents, HIPAA/PHI and electronic records
• Resources and tools for study site personnel

Professional Credit: CA BRN/LVN Credit--Provider #CEP13114.