The GCP U.S. FDA Basic course covers Good Clinical Practice (GCP) and U.S. Food and Drug Administration (FDA) essential topics for clinical trials with investigational drugs, biologics, and/or medical devices. It is intended for research personnel involved in drug, biologic, or device studies and who would benefit from FDA-focused training. It covers key topics in clinical research including:
- Reviewing FDA regulations
- Identifying investigator and sponsor obligations
- Discussing new drug development
- Comparing International Council for Harmonisation (ICH) GCP E6 and FDA regulations
- Describing how to detect and report adverse events
- Auditing and monitoring expectations
This course (English only) 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: Chinese, English, Korean, Spanish
Suggested Audiences: Clinical Research Coordinators, Conduct, Contract Research Organizations (CROs), Investigators, IRB Members, Key Study Personnel, or Management of Clinical Trials with Drugs and/or Biologics, Oversight, Research Nurses, Research Staff who are Involved in the Design, Sponsors
Organizational Subscription Price: Included in Good Clinical Practice (GCP) series for $1,000 per year/per site
Independent Learner Price: $129 per person