Institutional Review Board (IRB): Lead Institution’s Obligations
The home institution of the lead Principal Investigator (PI) will be responsible for data reporting, negotiations and communications with the funding entity, oversight of any Data Safety Monitoring Board (as applicable), approval of quality assurance and monitoring plans, regulatory filings, and IRB oversight. All sub-investigators will submit the required data (e.g., SAEs, deviations, etc.) to the coordinating site’s IRB. In addition, each party shall be responsible for monitoring the conduct of its own PI and other research personnel participating in a consortium study and ensuring compliance with all applicable federal, state, and local laws and regulations.
Data Ownership
Any data generated as part of a consortium study will belong to the party whose PI generated such data. Each party gives the other parties the right to use data generated in performance of a consortium study for their own academic, internal non-commercial research, and patient care use.