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Options for Fulfilling HRPP and GCP Training Requirements

NOTE: Training in BOTH human subjects research and Good Clinical Practices (GCP) is required every two years. Some of the courses listed below fulfill only human subjects or GCP, and necessitate taking a second course to complete the training requirements. It is not necessary to take a different course every other year. You may choose to repeat a course to satisfy the training requirements.

The following is a list of VA courses and non-VA courses that have been approved by the Office of Research and Development. Your local affiliate course may be ORD approved. ORD approves all Office for Human Research Protections (OHRP) courses to satisfy the every two years human research training requirement (OHRP does not have a GCP course to fulfill that training requirement).

K. Lynn Cates, MD
Assistant Chief Research & Development Officer
Director
Office of Research & Development
Department of Veterans Affairs
810 Vermont Ave NW (10P9P)
Washington, DC 20420
Fax: (202) 254-3128
Email: lynn.cates@va.gov


VA Courses

The following online courses or face-to-face meetings satisfy the ORD two-year requirement for training in BOTH Good Clinical Practice and ethical principles of human research protection.

1. ORD and Collaborative IRB Training Initiatives (CITI)have developed a training curriculum that satisfies ORD training requirements. The curriculum includes a basic and a refresher track for both biomedical and social/behavioral research:

a. CITI Basic Course for those who have never taken the basic course on Human Subjects Protections and GCP through CITI. This course consists of nine modules. b. CITI 101 Refresher Course, consisting of seven modules, for those who have taken the basic course.

All CITI certificates of completion earned and records of modules completed are accessible in the CITI software. If you wish to receive CEU credit for this training, you can find more information here. If you have any questions about registering for CITI, please contact Dr. Mike Fallon at michael.fallon@va.gov.

2. PRIM&R Annual Conference

a. 2011 Advancing Ethical Research Conference, December 2-4, 2011, National Harbor, MD b. 2012 Advancing Ethical Research Conference, December 4-6, 2012, San Diego, CA c. 2013 Advancing Ethical Research Conference, November 7-9, 2013, Boston, MA d. 2014 Advancing Ethical Research Conference, December 5-7, 2014, National Harbor, MD

For more information, go to http://www.primr.org/conferences.aspx?id=56

3. PRIDE Sponsored Meetings

a. 2012 VA IRB Administrators Meeting- Chicago, IL, May 30-31, 2012 b. 2012 VA HRPP Meeting- San Francisco, CA, June 26-27, 2012 c. 2012 VA IRB Chairs Meeting- Baltimore, MD, August 14-15, 2012

4. VA CSP Best Practices for Clinical Researchers or HSP Training for Investigators. Either face-to-face training satisfies the ORD two-year requirement for training in both Good Clinical Practice and ethical principles of human subjects protection. Contact Cooperative Studies Program Site Monitoring Auditing & Review Team (SMART) (505) 248-3203.

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Non-VA Courses

Type of Course

Name and Description of Course

Human Subjects ONLY

National Cancer Institute: Protecting Human Research Participants
Note: Does not fulfill the GCP part of the training requirements.

Human Subjects ONLY

OHRP/PRIM&R “Investigator 101” CD ROM: Your local R&D Office can obtain a copy of the CD ROM and test booklet by contacting priscilla.craig@va.gov at ORO Central Office (202) 565-8162.

Note: Does not fulfill the GCP part of the training requirements.

Human Subjects ONLY

Dunn CM and Chadwick G. Protecting Study Volunteers in Research: A comprehensive manual designed to assist clinical research professionals in providing the highest standards of safety and ethical treatment for their study volunteers. Developed in accordance with ACCME standards, readers can apply for CME credits and Nursing Contact Hours. An exam is provided with each manual.

Note: Does not fulfill the GCP part of the training requirements.

GCP ONLY

ClinfoSource Online GCP Training - CRISP (Clinical Research Training for Investigational Site Personnel):This course is CME/CNE Accredited. The 10-module course (Course 11) is priced at $460 for individual registrants. They offer a 10% government discount and a volume discount on a sliding scale. The CME/CNE credit fee of $35 is extra and payable directly to the accrediting body.

Note: Does not fulfill the human subjects part of the training requirements.

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