December 10-12, 2024
The primary goal of this clinical investigator training course is to provide participants with the essential knowledge and skills to conduct clinical trials effectively, ethically, and in accordance with regulatory standards. The course aims to prepare clinical investigators to conduct high-quality research that contributes to scientific knowledge and improves patient care.
Participants will acquire a practical understanding of:
- Clinical investigator responsibilities
- FDA’s approach to trial design
- Statistical issues in the analysis of trial data
- Safety concerns in the development of medical products
- Understanding preclinical information relevant to medical product development
Intended Audience
This clinical investigator training course is intended for all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both domestic and foreign). The agenda is designed for:
- Clinical investigators
- Health care professionals (physicians, nurses, pharmacists, other healthcare workers), and
- Individuals involved in biomedical research and the development of drugs and biological products
Topics Covered
- Study design and protocol development
- Biostatistics and data analysis
- Ethical considerations
- Safety considerations for clinical trials
- Data management and integrity
- Regulatory requirements and compliance
- Innovations in trial design and implementation
Resources
visit the FDA.gov webpage
Enroll in the CITC 2024 Course
Enroll in the CITC 2024 course to access all lessons and resources.
Create a free FDA Learning Cache account or sign in with your existing account to get started.