On this Page
- What is a Clinical Research Associate (CRA) in clinical trials?
- Where is it used in clinical trials?
- How does Clinion implement it?
- What does it look like in practice?
- Related Terms
- Related Articles
- Category
What is a Clinical Research Associate (CRA) in clinical trials?
A CRA is a trained professional responsible for monitoring clinical trial sites to ensure compliance with study protocols, Good Clinical Practice (GCP), and regulatory standards. They verify participant safety, confirm data accuracy, and track study progress through site visits, remote monitoring, and oversight activities.
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?
CRAs operate throughout study conduct, from site initiation and training to ongoing monitoring and trial close-out. They check source documents, validate informed consent forms, follow up on queries, and resolve discrepancies. CRAs also liaise between sites, sponsors, and CROs to maintain quality, address site challenges, and ensure regulatory compliance.
How does Clinion implement it?
Clinion supports CRAs by providing dashboards that consolidate site data in real time, highlight outstanding queries, and flag protocol deviations. The platform integrates EDC and RTSM, allowing CRAs to track study metrics, monitor data quality, and oversee site performance. Role-based permissions ensure CRAs access only the data relevant to their oversight responsibilities, and audit trails capture every monitoring action.
What does it look like in practice?
A CRA logs into Clinion to assess site performance across multiple locations. They validate participant records, follow up on unresolved queries, and confirm adherence to visit schedules. Alerts guide them to priority tasks, and every review or intervention is logged automatically, producing a complete, traceable record of site oversight ready for audits or inspections.
Category
Roles & Permissions