The FDA offers training related to our good clinical practice (GCP) regulations and partners with other federal agencies and organizations across the United States to conduct additional training.
Clinical Investigator Training Course
FDA's Critical Path Initiative launched a clinical investigator training course for medical professionals who participate in FDA-regulated clinical trials. This three-day course includes lectures given by senior FDA experts and guest lecturers from industry and academia. It provides FDA's perspectives on new safety concerns, adverse event monitoring, compliance with legal and ethical obligations of clinical research and acceptable scientific and analytic standards in clinical study design and conduct. Register for the upcoming course or see the materials from recent courses for more information.
FDA clinical trial requirements, regulations, compliance and GCP conference
FDA co-sponsors two-day workshops with the Society of Clinical Research Associates (SOCRA). See SOCRA’s upcoming conferences and courses for more information.
Additional training opportunities
FDA routinely collaborates with HHS’ Office for Human Research Protections and the Department of Veterans Affairs on regional programs focused on protecting people participating in clinical trials. See FDA’s workshops and meetings, CDERLearn, CDRH Learn and HHS’ upcoming educational events for more information.
Other federal agencies also provide training:
- Online training on human subject protection provided by HHS’ Office for Human Research Protections
- Clinical research training is a course developed by the National Institutes of Health to train its investigators. It is available for others to enhance their knowledge of clinical research.
FDA regularly presents at meetings of various professional organizations including the Drug Information Association (DIA), Public Responsibility in Medicine and Research (PRIM&R), the Association of Clinical Research Professionals (ACRP) and the Regulatory Affairs Professionals Society (RAPS).
- FDA's GCP and HSP regulations
- Preambles to HSP and GCP regulations
- ICH E6 (R2) Good Clinical Practice Consolidated Guidance [261KB PDF]
- Bioresearch Monitoring (BIMO) compliance programs
- Clinical trials guidance documents and information sheets