- Review completed participant visits within the CRIO eSource platform using established quality control processes.
- Verify that all protocol-required procedures, assessments, and documentation have been completed accurately.
- Evaluate documentation against ALCOA and ALCOA+ principles to ensure data integrity.
- Identify missing documentation, inconsistencies, protocol deviations, and transcription errors.
- Complete standardized QC Checklists to ensure consistency across studies.
- Document findings thoroughly and escalate significant quality issues.
- Collaborate with site personnel to communicate findings and support timely resolution.
- Monitor corrective actions and follow-up activities as assigned.
Quality Assurance