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 reportsSafety and efficacy requirements
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?
- 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.
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.