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.
* NIH in fulfillment of their GCP training policy (Policy on Good Clinical Practice Training for NIH Awardees Involved in NIH-funded Clinical Trials; NOT-OD-16-148) states that NIH-funded investigators and staff should be trained in GCP. The NIH does not endorse any specific training programs. CITI Program offers several GCP courses that are considered acceptable by many leading organizations to meet their training needs per NIH policy released on 16 September 2016.
Language Availability: English
Suggested Audiences: Individuals who have already completed a basic level GCP course
Organizational Subscription Price: Included in Good Clinical Practice (GCP) series for $1,000 per year/per site
Independent Learner Price: $129 per person