On the Site Information Questionnaire, the Quorum asks the site to confirm that the Principal investigator and research staff understands the role of the Ethical Review Board, the importance of the informed consent process, and other pertinent aspects of human participant protection. If Human Research Participant Protection Training has not been conducted, the Board may require additional investigator or staff training.
Quorum expects Principal investigators to be responsible for the conduct of research trials and all associated research facilities consistent with the IRB-approved protocol, applicable law and regulations, applicable federal and ICH Guidelines for Good Clinical Practice, and ethical principles of the Belmont Report.
CITI stands for the Collaborative Institutional Training Initiative. This program provides training modules in Good Clinical Practice, Basic Courses in the Protection of Human Research Subjects, Responsible Conduct of Research (RCR), and a variety of other subjects. Quorum provides access for Principal investigators and study coordinators, and other study staff. Please see the Instructions for joining CITI through Quorum Review for information on how to initiate CITI training.
Read more about Quorum Review’s CITI training here
Yes. On the Central Study Questionnaire that is required with new study submissions, Quorum asks if the investigator would like Quorum to send a representative to attend the investigator meeting and provide training. This is a great way for sites to learn how to work with Quorum and can ensure complete site submissions and fewer questions later in the study regarding safety reporting, continuing review, and study closure. Please contact Initial Study Support if this is something you’d be interested in.