Training and Continuing Education

Regulatory Education for Industry (REdI): Clinical Investigator Training Course

Clinical Investigator Training Course

November 13-15, 2018

Experts from FDA’s Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Devices and Radiological Health (CDRH), the University of Maryland and the University of Pennsylvania will provide a deep dive into the scientific background and practical methodology needed when conducting clinical trials.

In this intensive course, attendees will learn FDA regulations, ethical considerations, and the scientific principles to help them understand what is important when conducting clinical trials and preparing a submission for FDA review.   

About the Training Course

Topics include:

  • Preclinical and clinical science
  • Statistical structure of trials
  • Safety and ethical requirements
  • FDA regulatory requirements related to the performance and evaluation of clinical studies
  • Non-clinical, early clinical, and phase 3 studies
  • Issues in the design and analysis of trials

After this course, the participant will be able to:

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

Back to Top

Slides and Recordingsdisclaimer icon

Location
Tommy Douglas Conference Center (TDCC)
10000 New Hampshire Avenue, Silver Spring, MD 20903

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

Speakers
FDA medical officers, FDA senior scientists, FDA senior experts, and guest lecturers from academia and patient advocacy will provide presentations.

Back to Top

Continuing Education Information

This course is eligible for up to 19 CE credits for physicians, nurses, pharmacists, or pharmacy technicians. Please refer to the course CE announcement for complete information.

This event is eligible for up to 12 credits towards a RAC recertification.

A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.
 

http://www.pharmacy.umaryland.edu/media/SOP/wwwpharmacyumarylandedu/CERSI-files/cersi-logo.png

A collaborative partnership between the University of Maryland, College Park and the University of Maryland, Baltimore, with support from the Food and Drug Administration (FDA), the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) focuses on modernizing and improving the ways drugs and medical devices are reviewed and evaluated.

2013 Clinical Investigator Training material is available in the FDA Archive 
2016 Clinical Investigator Training material is available in the FDA Archive 
 

Back to Top

Page Last Updated: 12/18/2018
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English