As we partner to ensure the rights and welfare of human research subjects it is crucial that we work together under adequate assurances regarding regulatory obligations related to human subject protection. Copernicus Group IRB requires the research sponsor to assure the following:

• All principal investigators (PIs) in the United States and territories are qualified to conduct clinical research through GCP training and proper experience.
• The protocol, subject information and consent form, and clinical investigator brochure (CIB) will be submitted to CGIRB for initial review by the CGIRB Board.
• All unanticipated problems involving risks to subjects or others will be reported by the sponsor or an investigator to CGIRB promptly (not to exceed 5 business days).
• Investigator packets will include a copy of 1572 (if applicable – eg, IND, FDA-regulated study), CGIRB Investigator Site Questionnaire, PI current curriculum vitae (signed and dated), and copy of valid medical license for PI.
• Continuing Review Status Reports, Unanticipated Problem Report Form and Coversheet, Investigator Site Closure Request and Final Study Status Reports will be submitted directly to CGIRB by PIs. (see forms)
• PI noncompliance (serious or ongoing), fraud, or misconduct will be reported promptly to CGIRB (within 5 business days).
• A written plan will be submitted for providing medical care and compensation for medical care for research subjects that experience a related injury during the study.
• Sponsors/institutions will provide a prompt report of any findings from the research, including the safety and effectiveness of the study drug/device, that could affect the safety of subjects or their willingness to continue participation, influence the conduct of the study, or alter CGIRB's approval to continue the study.
• Whenever the safety or medical care of a research subject could be directly affected by study results, sponsors shall promptly provide sufficient information regarding the results and the potential impact on subject safety and medical care to ensure that there is direct communication to the subjects in a manner to be approved by CGIRB.

Please also see our Investigator Obligations.