Human Subject Training/Resources
Required for all Clinical Research Staff

Duke Office of Clinical Research (DOCR) Duke Human Subject Research (HSR) Training Class –
(mandatory for all Clinical research staff and faculty) scheduled through DOCR Web site (2 hrs.)
http://docr.som.duke.edu/
Optional Courses (attendance to be determined by Principal Investigator and job description)
Informed consent
Research Data Integrity/Data Security,
IRB Overview
Study Documentation: Regulations and Best Practices
Urine Pregnancy Screening*
Phlebotomy Competency for Research**
Maestro Care Training if Access is needed

Meet CRU Leadership
Research Practice Manager (Sharon Minda)
Financial Practice Manager (Renee Vaughan) should meet with personnel involved in any billing
activity

OESO On-line training Modules
www.safety.duke.edu/OnlineTraining
Required to complete before 90-day orientation and evaluation period
Fire Safety
Compliance Update Training
HIPAA Privacy and Security Training
Equity at Duke

CITI Modules https://www.citiprogram.org/
Create a new account and "Affiliate" with Duke Medicine
Belmont Report/ CITI Course Introduction
History and Ethical Principles
Basic Institutional Review Board (IRB) Regulations and Review Process
Informed Consent
Research with Protected Populations – Vulnerable Subjects: An Overview
FDA-Regulated Research
Optional Courses ( Vulnerable Populations/ Children if you will be working with subjects under
18) This is a required course.
*Require annual update
** Any of the courses above can be taken on-line at http://docr.som.duke.edu/education/registertrainings at the discretion of the Research Practice Manager, the Supervisor and the PI.
Resources
DUHS HRPP Policies – accessed via eIRB
Duke Employee Handbook – Provided at initial employee training and available on Duke
Human Recourses http://www.hr.duke.edu/policies/index.php
CRU (Edward Suarez/Sharon Minda)
Psychiatry Human Resources (Gail Sexton)
1