GCP FDA Refresher
GCP FDA Refresher is organized by the Collaborative Institutional Training Initiative (CITI Program).
Description :
GCP FDA Refresher reinforces the importance of concepts covered in the basic level GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) course. This course meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. CITI Program GCP training is used by over 1,500 institutions – (including many leading hospitals, academic medical centers, universities, and healthcare companies) – to meet their GCP training needs. The National Institutes of Health (NIH)* requires completion of GCP training that demonstrates that individuals have attained the fundamental knowledge of clinical trial quality standards for designing, conducting, recording, and reporting trials that involve human research participants.
