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. The narrative illustrates, from the investigator’s perspective, real-world examples of the information being presented, from communication strategies with the reviewing Institutional Review Board (IRB) to ensuring legally effective consent from subjects is obtained.
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.
