responsible for internal monitoring, validation, and auditing of participants' source documents, CRF files, appropriate clinical staff Assist staff with GCP and audit-compliant resolution of all monitoring findings specified records prior to site monitoring visits, audits, or inspections Review Site Monitoring Reports
responsible for internal monitoring, validation, and auditing of participants' source documents, CRF files, appropriate clinical staff Assist staff with GCP and audit-compliant resolution of all monitoring findings specified records prior to site monitoring visits, audits, or inspections Review Site Monitoring Reports
with the data manager to regularly monitoring and audit the database, including data verification, run data protocol adherence Review quality assurance records, audit reports, corrective actions, and compliance documentation documentation Review reports on quality control findings, audit results, and corrective actions by the quality assurance
with the data manager to regularly monitoring and audit the database, including data verification, run data protocol adherence Review quality assurance records, audit reports, corrective actions, and compliance documentation documentation Review reports on quality control findings, audit results, and corrective actions by the quality assurance
partners, regulatory bodies, donor monitoring and auditing agencies, and others as necessary Maintain close
partners, regulatory bodies, donor monitoring and auditing agencies, and others as necessary Maintain close