Glossary
Stakeholder
Any individual, group, or organisation that can affect, be affected by, or perceive itself to be affected by a risk.
Source · ICH Q9(R1) (2022), §7 Definitions: Stakeholder
Details
Different stakeholders may perceive the same risk differently, so decision making must give priority to protecting the patient while bringing in the right expertise and perspectives. Inspections may find a single department assessment weak where key functions, contract acceptors, regulatory requirements, or the patient impact perspective were left out. Look at the composition and roles of the team, meeting and review records, risk communication, and the basis for approval.
Related sections
Related terms
Source
ICH Q9(R1) (2022), §7 Definitions: StakeholderGRM Regulatory Glossary
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