Expectations

The following is a list of responsibilities for Principal Investigators (PIs) engaging with the FIRST Program to conduct Industry funded clinical trials:

• Review and sign-off on all study contracts and budgets
• Meet weekly with the FIRST team while the study is active
• Respond within 48 hours to FIRST team emails related to the study
• Provide FIRST Team with a cell phone number or pager number to access PI for emergent issues related to the study
• Assess Inclusion and Exclusion criteria for all subjects enrolled
• Assess Serious Adverse Events/Adverse Events (SAE/AEs) for subjects enrolled in the study. PI must assess SAEs within 24 hours
• Review and sign-off on all regulatory work completed by FIRST Team on the PI’s behalf in a timely manner (24 hours for SAEs and 1 week for non-urgent regulatory submissions)
• Responsible to complete all training related to the protocol
• Responsible to attend any study meetings with the Sponsor (Site Initiation Visit and meetings with monitors)

Additionally, we have created a checklist of required material needed for new protocols seeking full regulatory and/or staffing support for new research projects. This checklist can be downloaded here.