Conducting Clinical Research

Training Requirements

Training is a key requirement for conducting clinical research. Training programs available at Downstate include protection of human subjects, Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPAA) privacy and security and laboratory safety training for handling of biological specimens. Secondary to these general clinical research training programs, having processes in place for training study teams on individual Institutional Review Board (IRB) protocols and amendments is critical to meet the expectations of the Food and Drug Administration (FDA) and sponsors.

Who needs training?

All study personnel involved in the design and/or conduct of research involving human subjects are required to receive adequate training. Study personnel include investigators, physician assistants, nurse practitioners, research nurses, pharmacists, data managers, regulatory coordinators, laboratory technicians and any assistants/volunteers directly involved with the research.

What trainings are required prior to being involved in clinical research using human subjects?

The chart below outlines the mandatory trainings.

IRB Human Subjects Training	Required: Biomedical Investigators using Human Subjects, Clinical Research Investigators and Key Personnel Click here for access to training course	Refresher required every 4 years
HIPAA	Required: HIPAA Privacy HIPAA Security Click here for access to training course	Comprehensive training required initially; Subsequently, annual refresher training requiredy
Environmental Health & Safety (EHS) Training Courses	There are three modules for the Environmental Health and Safety Training Courses: Laboratory Safety Clinical and General Safety Biological Material Shipment Training Click here for access to training course	Required Annually
Healthbridge EMR Training	Required: Contact your department administrator to schedule training	Required one time only
Conflicts of Interest	Required: All Investigators and key personnel involved in research must complete this course. Click here for access to training course	Required every four years.

Note that it is always best to keep electronic copies for yourself.

There may be additional training (optional or required) for your specific research role including those listed below. Many of these training modules are available through the campus-wide CITI program: https://www.citiprogram.org/

Protocol-specific training
Orientation and review of your department's Standard Operation Procedures (SOP)
Biological material shipment
REDCap, or other electronic data capture systems as needed.