Monitoring and Audits

What

The sponsor or CRO routinely conducts monitoring visits to verify that the:

• Rights and well-being of subjects are protected
• The data is accurate, complete and verifiable
• The conduct of the trial is in compliance with the protocol, with GCP and with the applicable regulatory requirement(s) (ICH GCP 5.18.1)

How

In preparation for a monitoring visit, the site must ensure there is available space for the monitor (with access to the internet and copy machine), the PI is available to meet the monitor, an appointment to visit IDS visit is scheduled (if applicable), the regulatory binder, informed consents, CRFs and medical records are available. Study teams should consult with their departments or CTO offices for specific policies and procedures relating to monitor visits.

IDS Scheduling - All routine monitor visits with IDS must be scheduled at least 2 weeks in advance. The first monitoring visit should be conducted within 2 weeks of treating the first patient; therefore an exception can be made for scheduling first time visits. During the visit, the CRA will perform a thorough accountability of drug supply, storage, and temperature control. Temperature logs will be provided at each monitoring visit from the time since the last visit.

Due to limited storage capacity, during routine monitoring visits, the monitor should be informed to be prepared to authorize return/destruction of used/expired investigational product.

Guidance and Recommendations for On-site and Remote Study Monitoring  (Updated 1/26/2021)

• Click > HERE (internal) for:
  • Remote Monitoring Guidance and Recommendations
  • Guidance – Use of Certified Copy

(Note: to access internal documents in SharePoint, you may be prompted to enter your MSHS credentials.)

• Refer to COVID-19 Human Subject Research Ramp-up Guidance for the latest monitoring updates from the Dean's Office.
• For guidance on Requesting External Monitor and Auditor Access in Epic click > HERE.

Policy Updates

Update on On-site Monitoring for Clinical Trials (10/04/2022)

Monitoring for Clinical Trials

• Effective October 4, 2022, more than one monitor may be on the premises as space allows.
• Monitors will not be required to show proof of vaccination or a negative test. However, they still have to wear masks and New York State requires us to keep doing symptom check for patients and visitors at the entrances to our facilities.
• Please continue to contact pharmacy at least 2 weeks in advance to schedule visits.

If you have any further questions, you can also reach out to Rosalind Wright, MD MPH at rosalind.wright@msssm.edu.

What

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.

How

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.

BRANY Audits

BRANY performs routine study audits of investigators who are using their IRB services. Study teams will be notified and an audit visit will be scheduled.

External Monitor and Auditor Access to Epic – Click here.

What

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.

How

Announced 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