Options for Fulfilling HRPP and GCP Training Requirements

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

If you have any questions, please contact

Marisue Cody, PhD, RN
Director, COACH
(202) 461-1814
Marisue.Cody@va.gov


VA Courses

The following three courses cover BOTH Human Subject Protection and GCP. ORD and Collaborative IRB Training Initiatives (CITI) have developed a VA training curriculum to satisfy the ORD annual training requirements. This curriculum includes three courses that build upon each other over three years:

  1. A Basic Course for those who have never taken the VA basic course on Human Subjects Protections and GCP either through CITI or through EES. (EES no longer hosts training after December 2006). This course consists of nine modules.
  2. CITI 101 Refresher Course, consisting of seven modules, for those who have taken the VA basic course.

You will have access to previous training and certificates that you have taken with CITI. All CITI certificates of completion earned between March 2004 and December 2006 are accessible in the new software, and records of any modules completed in the past are transferred and credited in the new 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.

VA Human Research Protection Program (HRPP) 101: This face-to face training satisfies the ORD annual requirement for training in both Good Clinical Practice and ethical principles of human research protection.

VA CSP Best Practices for Clinical Researchers. This face-to- face training satisfies the ORD annual 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) 248-3206.

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Non-VA Courses

 

Type of Course

Name and Description of Course

Human Subjects ONLY

National Cancer Institute:Human Participant Protections Education for Research Teams

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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