Clinical Investigator Training Course

Offered byFDA

Provider Info

Courses

Course Info

Clinical Investigator Training Course
at
FDA
Overview

Exploring the Subtleties of Clinical Investigation: A Comprehensive Training Course

Duration	6 hours
Mode of learning	Online
Official Website	Go to Website
Credential	Certificate

Clinical Investigator Training Course
at
FDA
Highlights

Earn a certification after completion

Clinical Investigator Training Course
at
FDA
Course details

Who should do this course?

Physicians, nurses, pharmacists and other healthcare professionals responsible for the conduct in clinical trials.

What are the course deliverables?

Explain the responsibilities of an investigator conducting a clinical trial
Describe what to look for in medical products being studied in a clinical trial
Describe the basic concepts of clinical trial design
Review clinical data for sources of bias and error

More about this course

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.

Clinical Investigator Training Course
at
FDA
Curriculum

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