March 17, 2017
Notification of NIH Good Clinical Practice Training Requirement
Effective: January 1, 2017
The Office of the Vice President for Research (OVPR) would like to inform faculty involved with clinical trials about the NIH Good Clinical Practice Training requirement, effective January 1, 2017.
On September 16, 2016, the National Institutes of Health (NIH) issued a new policy for all NIH funded investigators and site staff who are involved in the conduct, oversight, or management of clinical trials (see Notice Number: NOT-OD-16-148). A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
The policy establishes that these NIH awardees and clinical trial staff* should be trained in Good Clinical Practice (GCP) consistent with the principles for the International Conference on Harmonisation (ICH) E6. Please note that this requirement pertains to trials of behavioral interventions as well. According to the NIH, “The principles of ICH (E6) apply generally to all clinical trials. Some measures, e.g., reporting of adverse drug reactions to regulatory authorities, are pertinent specifically to trials of interventions involving drugs and devices, rather than to trials of behavioral interventions. However, the underlying principle of safety monitoring and reporting is relevant to all clinical trials and can be a guide to behavioral investigators in their monitoring and reporting of safety events to relevant oversight bodies, e.g., the Institutional Review Board.”
The training requirement is effective as of January 1, 2017 and personnel are expected to complete it by April 30, 2017. The requirement will be satisfied through completion of an on-line training module approved by the Associate Vice President for Research Integrity and Regulatory Affairs. UConn will use on-line modules provided through the Collaborative Institutional Training Initiative (CITI) for GCP.
Investigator Procedural Steps
- CITI Training Course Login:
Individuals log in to the CITI website (https://www.citiprogram.org/) to complete GCP training. Review question 8 and select a module(s) based on your primary research function.
- Principal Investigators are responsible for ensuring that key personnel (as defined in note below) complete the GCP Training course by April 30, 2017. This responsibility extends to personnel added during the course of the study by amendment.
- The NIH application should be completed correctly to identify that the project is considered a clinical trial as defined above and in accordance with the NIH Grants Policy Statement.
IRB Staff Responsibilities
IRB Staff will verify that all applicable investigators and site staff have completed the required training. Verification will be study specific and done for all ongoing and new NIH funded clinical trials. To be considered valid and current, the GCP training must be renewed every three years. Failure to complete GCP training for new NIH funded clinical trials or to renew GCP education every three years may impact the ability to access your NIH funds and to obtain or maintain IRB approval.
If you have any questions, please contact Doug Bradway at 6-0986 or by email at firstname.lastname@example.org.
* Individuals identified by the investigator, who are responsible for study coordination, data collection and data management. The central focus of clinical trial staff is to manage participant recruitment and enrollment, to maintain consistent study implementation, data management, and to ensure integrity and compliance with regulatory and reporting requirements. These individuals may also seek informed consent from prospective participants, enroll and meet with research participants, and collect and record information from research participants. Clinical trial staff may also be called the research coordinator, study coordinator, research nurse, study nurse or sub-investigator.