Reviews the important role of the biomedical investigator (also referred to as the clinical investigator or principal investigator [PI]) in a clinical investigation that complies with federal regulations and Good Clinical Practice (GCP) standards. This course is designed for individuals new to the investigator role or those seeking a focused, role-based course.
A fictional narrative of an investigator responding to an FDA Warning Letter and reflecting on his imperfect supervision and conduct is interspersed throughout the course. This narrative establishes context for the discussion of regulatory requirements and GCP standards. Further, the narrative combined with the course content provides practical information in the areas of supervision, delegation, management, informed consent, reports, and communication.
This course also provides supplemental tools available for download, including example standard operating procedures (SOPs), checklists, and templates.
This course was created by Cindy Gates, RN, JD, CIP, and peer reviewed by experts.
Language Availability: English
Suggested Audiences: Biomedical Investigators, Clinical Investigators, Investigators, Principal Investigators, Sub-investigators
Organizational Subscription Price: $675 per year/per site for government and non-profit organizations; $750 per year/per site for for-profit organizations
Independent Learner Price: $99 per person