IRR Roadmap By Role

Successful return of IRR can only come from the collaboration of all stakeholders within the clinical trial ecosystem. Different roles will have different priorities, concerns, and responsibilities.

On the following pages we provide a roadmap for the IRR journey for specific stakeholders: Research sponsors, IRBs/HRPPs, Study teams/Site staff/Investigators, and Patients/Participants.

These summaries are intended to be high-level reviews of the roles and responsibilities of each group, and they link/refer to detailed guidance, tools, and case studies as applicable.

Research Sponsors

Those developing treatments and financing clinical trials.

IRBs/HRPPs

Those providing ethical reviews of research or managing human research protections programs.

Investigators, Study/Site Staff

Principal Investigators, study team members, and staff at research sites.

Patients/Participants

Those participating in or considering clinical trials, and their family members/caregivers.

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