Regulatory Education for Industry Clinical Investigator Training Course
Tuesday, November 12, 2019
University of Maryland, College Park
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.