Enhance your clinical trial expertise for free with the FDA Clinical Investigator Training Course
Closing Date: Ongoing
Enhance your clinical trial expertise for free with the FDA Clinical Investigator Training Course
About the Event
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
Course Structure
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
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