During a clinical trial, the sponsor will sometimes send a representative known as a monitor to your site to review the study’s progress. This course will discuss how to plan and conduct those monitoring visits. Read more
During a clinical trial, the sponsor will sometimes send a representative known as a monitor to your site to review the study’s progress. This course will discuss how to plan and conduct those monitoring visits. Read more
This course covers the fundamental concepts and processes for managing study amendments, maintaining regulatory compliance within clinical trials, ongoing financial management responsibilities and expectations for clinical trials, and conducting study closeout. Read more
This course covers the fundamental concepts and processes for managing study amendments, maintaining regulatory compliance within clinical trials, ongoing financial management responsibilities and expectations for clinical trials, and conducting study closeout. Read more
The US Food and Drug Administration (FDA) has a comprehensive program of on-site inspections and data audits to monitor the conduct of reporting of FDA-regulated research. The aims of these programs are to provide uniform guidance and specific instructions for conducting clinical investigator inspections and to gather evidence to support the regulatory decision-making process. This course is designed to help clinical investigators understand the goals of the inspections, prepare for them, and how to conduct any post-inspection follow-up. Read more
The US Food and Drug Administration (FDA) has a comprehensive program of on-site inspections and data audits to monitor the conduct of reporting of FDA-regulated research. The aims of these programs are to provide uniform guidance and specific instructions for conducting clinical investigator inspections and to gather evidence to support the regulatory decision-making process. This course is designed to help clinical investigators understand the goals of the inspections, prepare for them, and how to conduct any post-inspection follow-up. Read more
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