Monitoring and Audits
Internal Audits - Research Compliance
Research Compliance performs routine study audits to ensure that the human subject research conducted at Icahn School of Medicine at Mount Sinai meets federal as well as institutional regulations and to ensure that trial data is accurate, complete and verifiable.
Research Compliance will notify the principal investigator if they are selected for an audit. During an audit visit regulatory documents as well as subject records will be reviewed by Research Compliance. Subsequent findings, corrective actions and recommendations will be communicated to the principal investigator through an audit report. The IRB will also receive a copy of the audit report.
External Monitor and Auditor Access to Epic – Click here.
External Agency Audits (FDA, OHRP)
External agencies such as the US Food and Drug Administration (FDA) and Office of Human Research Protections (OHRP) may conduct “routine” or “for cause” audits or inspections.
If your site receives notification of an audit by the FDA or OHRP, contact Research Compliance immediately. The Principal Investigator and study team should also notify PPHS and the IRB of record if it is not PPHS. Research Compliance provides guidance, tools and templates to assist study teams prepare for an audit.
External Monitor and Auditor Access to Epic – Click here
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