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  4. FDA Clinical Investigator Training Course (CITC) 2024 - 12/10/2024
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Conference | Virtual

Event Title
FDA Clinical Investigator Training Course (CITC) 2024
December 10 - 12, 2024

Date:
December 10 - 12, 2024
Day1:
Tue, Dec 10 11:00 a.m. - 03:30 p.m. ET
Day2:
Wed, Dec 11 11:00 a.m. - 04:00 p.m. ET
Day3:
Thu, Dec 12 11:00 a.m. - 03:05 p.m. ET

Session Recordings

AGENDA

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ABOUT THIS EVENT (Hosted by CDER SBIA)

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:

  • 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
  • Clinical investigator responsibilities

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

LEARNING OBJECTIVES

  • Understand key considerations for the design of clinical trials
  • Review statistical concepts relevant to the analysis and interpretation of clinical trial data
  • Explain the responsibilities of clinical investigators in the conduct of clinical trials
  • Understand FDA regulatory requirements and guidance related to the design and conduct of clinical trials

FDA RESOURCES

The detailed announcement can be found at this link: U.S. Food & Drug Administration

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