Training Requirements

Training is a key component of conducting clinical research. It is essential to have comprehensive and standardized training requirements to ensure understanding of the regulations governing clinical research. These trainings 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 trainings, having processes in place for training study teams on individual 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 research? 
The chart below outlines the mandatory and optional trainings.

IRB Human Subjects Training

There are two components to the IRB Human Subjects Training:

Required: Biomedical Research Investigators and Key Personnel

Optional: Good Clinical Practice

IRB Information

Refresher required every 4 years

Required one time only

HIPAA

Required:

• HIPAA Privacy 
• HIPAA Security 

HIPAA Information

Required one time onlyEnvironmental Health & Safety Training Courses

There are three modules for the Environmental Health and Safety Training Courses:

• Laboratory Safety 
• Clinical and General Safety 
• Biological Material Shipment Training 

EHS Training Guide

Required Annually:
Laboratory Safety
Clinical and General Safety

Required Bi-annually:
Biological Material Shipment Training

EPIC – WCMC Electronic Medical Record 

Required: Contact your administrator to schedule EPIC training

For questions related to EPIC training please contact epictraining@med.cornell.edu

Required one time only

Please submit a copy of your training certificates to your designated departmental or divisional administrator/supervisor. Additionally, it is always best to keep electronic copies for yourself. If you have questions, please contact JCTOoperations@med.cornell.edu.

Guidance for Departmental Training
There may be additional training required for your specific research role including:

• Protocol-specific training 
• Orientation and review of your department’s Standard Operation Procedures (SOP)
• Eclipsys (NYPH Electronic Medical Record)
• IDEAL: Imaging Data Evaluation and Analytics Lab
• REDCap, or other electronic data capture systems