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- What is an Investigator in clinical trials?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
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What is an Investigator in clinical trials?
An Investigator is a qualified physician or healthcare professional responsible for conducting a clinical trial at a study site.
The Investigator ensures participant safety, follows the approved protocol, performs clinical assessments, and confirms the accuracy and completeness of trial data in accordance with Good Clinical Practice (GCP).
Where is it used in clinical trials?
The Investigator role is used at the study site across key phases of a clinical trial. Investigators are involved during study start-up to confirm protocol feasibility, during enrollment and treatment to oversee subject assessments, and throughout study conduct to evaluate safety data. They are responsible for confirming clinical findings, assessing adverse events, and ensuring protocol adherence. Investigators also play a role during monitoring and close-out activities by validating data that supports regulatory review, inspections, and final study outcomes.
How does Clinion implement it?
In Clinion, the Investigator is a system-defined site role that represents clinical responsibility within the platform. This role defines how oversight is structured digitally, including which study records require Investigator involvement and where formal acknowledgement is required. Clinion associates Investigator responsibility with specific study records and milestones, helping ensure regulatory expectations for oversight and documentation are built into the system rather than handled outside it.
What does it look like in practice?
In a Clinion-enabled study, the site team enters and prepares clinical data and routes it for Investigator action at predefined stages. The Investigator accesses the platform to review subject visits, assess reported safety information, and complete required acknowledgements. Once completed, records move automatically to the next stage of review, reducing manual follow-ups and maintaining a clear, traceable workflow.
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Roles & Permissions