Acting Commissioner of Food and Drugs
Norman E. “Ned” Sharpless, M.D.
Deputy Center Director for Clinical Science and Senior
Immediate Office of the Office of New Drugs (OND) | Center for Drug Evaluation and Research (CDER)
Robert Temple, M.D.
Associate Director for Clinical Methodology
Office of Medical Policy (OMP) | CDER
Leonard Sacks, M.D.
This course provides a study of clinical trial principles with in-depth coverage of clinical trial design, issues in safety and efficacy, investigator responsibilities, understanding the investigator brochure, and FDA requirements across Centers.
Upon completion, attendees should understand pre-clinical research, clinical trials, and FDA submissions for licensure of medical products.
About the Training Course
- Clinical trial design and analysis, including new trends and key documents such as: protocol, informed consent, investigator’s brochure, health records, and study reports
- Safety and efficacy requirements
- Ethical considerations
- FDA regulatory requirements related to the performance and evaluation of clinical studies
- Non-clinical, early and advanced clinical studies
- Roles and responsibilities of the investigator
- Rationale for Good Clinical Practice (GCP), FDA regulations and inspections
- Basic statistical principles
Who Should Attend?
To maximize value of this course, we recommend attendees possess a basic understanding of clinical trials, regulatory requirements and medical product development.
Those who are involved in the clinical trial enterprise and are:
- Healthcare professionals (physicians, nurses, and pharmacists, clinical scientists)
- Drug, device, and biologic industry employees
- Regulatory affairs professionals
- Biomedical professionals
- Explain the responsibilities of an investigator conducting a clinical trial.
- Describe what to look for in drugs being studied in a clinical trial.
- Describe the basic concepts of clinical trial design.
- Review clinical data for sources of bias and error.
Speakers include subject matter experts from CDER, CBER, and CDRH, academia, and representatives from patient advocacy organizations.
- Centers of Excellence in Regulatory Science and Innovation (CERSI)
- 2018 Clinical Investigator Training Course
E-mail ClinicalInvestigator@fda.hhs.gov or call 301-796-8946.
- SOCRA 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.
- has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
- has been pre-approved by SQA as eligible for 0.25 non-GCP or non-GLP units for every 1 hour of instructional time towards a participant’s RQAP re-registration.
- has been approved by ACRP for medical education credits. Contact hours are provided at 1 unit for at least 45 minutes of qualified material.
The University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI), University of Maryland, and the FDA have partnered to modernize and improve the ways drugs and medical devices are reviewed and evaluated for licensure.