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  4. FDA Clinical Investigator Training Course (CITC) 2023 - 12/06/2023
  1. News & Events for Human Drugs


Event Title
FDA Clinical Investigator Training Course (CITC) 2023
December 6 - 7, 2023

December 6 - 7, 2023
- ET
- ET



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This course is designed to promote professionalism in the clinical trial industry for individuals involved with submissions to FDA (Investigational New Drug (IND) application, New Drug Application (NDA), Biologics License Application (BLA)), and to familiarize stakeholders with the regulatory and scientific issues involved in the development and approval of medical drugs and biological products. Participants will acquire a practical understanding of:

  • FDA’s approach to trial design
  • Safety concerns in the development of medical products
  • Statistical issues in the analysis of trial data
  • Clinical investigator responsibilities


This is a clinical investigator training course targeted at all stakeholders in the clinical trial enterprise including industry, academia, and regulators (both local 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.


  • Design and conduct of clinical trials
  • Innovative trial designs
  • Considerations for rare disease drug development
  • Enhancing diversity in clinical trials
  • Addressing specific populations in drug development
  • Statistical evaluation of clinical trials
  • Understanding the investigator brochure
  • Clinical trial quality



This event has been approved for a total of 9.75 contact hours of continuing education (CE) for physicians, pharmacists, and nurses. You can review the detailed announcement for further information. Registration and real-time attendance via Adobe Connect is required for CE eligibility.

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.


  • To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
  • Please contact info@sbiaevents.com for all technical questions.
  • If you encounter any technical issues before or during the event, please visit the Technical Issues Support
  • Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
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