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  1. CDER Small Business & Industry Assistance (SBIA)

FDA Clinical Trials Training Modules

This training represents regulatory intelligence that sets global standards for clinical research. 

The content reflects current FDA thinking, emerging guidance, and real-world regulatory experience, providing participants with the most reliable and up-to-date information available. Organizations utilizing this training demonstrate their commitment to regulatory excellence and position their teams for successful interactions with health authorities worldwide. 

Browse courses available on demand: 

SummaryCourse Description
FDA Clinical Investigator Training Course (CITC) 2024Prepare to conduct high-quality research that contributes to scientific knowledge and improves patient care.
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance SymposiumAccelerate your clinical development success with this comprehensive workshop featuring global regulatory experts who will deliver strategic insights on ICH E6(r3) implementation, risk-based trial design, and cutting-edge operational technologies that drive quality outcomes and regulatory approval.
FDA Clinical Investigator Training Course (CITC) 2023Learn about FDA’s approach to trial design, safety concerns in the development of medical products, statistical issues in the analysis of trial data, and clinical investigator responsibilities.
ClinicalTrials.gov – a Three-Part SeriesGain an understanding of CDER’s role and responsibilities with respect to ClinicalTrials.gov oversight and hear examples of compliance and enforcement activities CDER has taken to encourage compliance.
FDA Clinical Investigator Training Course (CITC) 2022Acquire a practical understanding of FDA’s approach to the evaluation of clinical trials, associated regulatory requirements, and other scientific issues related to investigational medical products.

More about FDA's Center for Drug Evaluation and Research's (CDER) Small Business and Industry Assistance (SBIA) Program

CDER SBIA serves as the primary point of contact for pharmaceutical industry seeking to connect with the Agency. Our mission is to help you navigate FDA's extensive regulatory landscape and master human drug product regulation requirements. Learn more here or watch our video below. Find additional resources for professional development in the CDER SBIA Learn Online Training Repository. 

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