Principal Investigators are ultimately responsible for the research conduct at their site. As such, all Principal Investigators and Co-Investigators covered by PrimeIRB must complete an NIH-accepted training for Good Clinical Practice (GCP) and Human Subject Protection (HSP). All CRO/Sponsor Investigators, as well as Site Principal and Co-Investigators wishing to rely on PrimeIRB as their IRB-of-record must also read the PrimeIRB Investigator Handbook.
Training requirements from PrimeIRB are not meant to substitute for your own institution’s requirements. Your institution may have specific training requirements in addition to those required by PrimeIRB. Please check with your institutional official to verify the training requirements for which you and your study team are responsible.
PrimeIRB will accept GCP and HSP training from any institution that is also accepted by the NIH. Some institutions may require their Investigators to complete training that is not considered GCP Training to fulfill their institutional requirements. This training will be accepted by PrimeIRB if a reliance agreement is in place.
As a value-added service, CITI training is available free-of-charge to investigators and study staff submitting to PrimeIRB. Users may register directly with CITI using the Prime Review Board account. Courses in GCP and HSP are available and upon completion, users will receive a certificate of completion from CITI. Contact email@example.com for more information.
General Information and Training Resources:
ICH E6 Training
The Belmont Report
OHRP Education and Outreach
ACRP: Introduction to Clinical Trials
ACRP: Ethics and Human Subject Protection: A Comprehensive Introduction
SOCRA Online Courses
Regulatory Affairs Professionals Society E-Learning
FDA and Good Clinical Practice Guidance:
Good Clinical Practice (GCP)/Clinical Trial Guidance
Clinical Trials and Human Subject Protection
Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors
Adverse Event Reporting to IRBs
Comparison of FDA and HHS Human Subject Protection Regulations