OVPRI performs routine risk-based monitoring on VCU-held IND/IDE studies, one-off monitoring visits on randomly selected studies, for cause monitoring and study initiation monitoring and education.
Goals of monitoring
- keeping participants safe and respecting their rights;
- having data we can trust;
- making sure the trial was run as it was meant to be;
- improving the way the trial is run; and
- preventing problems before they happen.
Study monitors may be tasked with spot-checking for inconsistencies or omissions, checking for completeness and consistency, source document verification and consistency between paper and electronic sources, identifying sites meriting further review, and the use of current consent and IRB documents.
Clinical studies in the US are overseen and may be audited by the Food and Drug Administration (FDA). Additionally, studies are overseen by the Institutional Review Board (IRB).
If you have a study that you would like to have monitored on a routine basis, please contact indide@vcu.edu.
If you have a study that you would like a one-off monitoring visit done, please contact regaffairs@vcu.edu.
Monitoring program standard operating procedures
FDA regulations
- Responsibilities of sponsors and investigators including monitoring investigations - drugs
- Responsibilities of sponsors - devices
- Responsibilities of investigators - devices
- Monitoring investigations - devices
FDA guidance
Monitoring templates
FDA compliance programs are overseen by the product centers (e.g., Center for Biologics and Research (CBER), Center for Devices and Radiological Health (CDRH), Center for Drug Evaluation & Research (CDER)), who may trigger directed inspections. The Office of Regulatory Affairs (ORA) receives assignments from the product centers, and tasks regional field inspectors. FDA publishes their bioresearch monitoring (BIMO) metrics annual report. Additionally, findings may be published in a warning letter.
The FDA’s Office of Regulatory Affairs publishes a summary of their inspection findings issued on FDA form 483s every fiscal year.
FDA inspections may be followed by FDA communications.
FDA communications containing findings foreshadow a ten-year follow-on FDA visit frequency enhancement.
Because resources are limited for principal investigators and their study teams, it may be instructive to know the most common FDA findings. Protocol deviations, that is failure to follow the investigational plan, are consistently a common finding. Documentation issues together with failing to follow the protocol may account for as much as 75% of all FDA findings.
Other issues include accurate case history record, informed consent, investigational product accountability, 1572 statement adherence, safety reporting, and 21 CFR 56 (IRB) deficiencies.
FDA has three types of inspection findings: (1) NAI – No action indicated, (2) voluntary action indicated, and (3) involuntary or “official action” indicated. Forewarned with knowledge, Investigators can marshal resources to best protect the rights, safety, and welfare of participants in the clinical investigation and the integrity of data generated during the investigation.
While in practice a rare occurrence, a sponsor or sponsor-investigator who discovers that an investigator is not complying shall promptly either secure compliance, or terminate the investigator's participation.
Vehicles for monitoring include site visits, Data and Safety Monitoring Committee (DSMC) meetings, interim and closeout visits. Audits may include random and directed audits. Monitoring may include risk-based monitoring, routine, for cause, or in anticipation of marketing approval regulatory filings.
Risk-based monitoring attempts to better protect patients by monitoring higher risk studies more frequently and more completely. For example, a first in human study using a second or third drug in an old drug class presents less risk to patients than a first in human study with a first drug in a new drug class. By more closely monitoring higher risk studies, patients are better protected given the resourcing available.
For cause monitoring provides enhanced monitoring of previously identified issues. For-cause visits (FCVs) are conducted to address any unanticipated issues that arise which require training, remediation or other situations in which the site requires assistance. For-cause visits can be mandated by OVPRI, its designees, or can be requested by the site.
Contact us
Lauren Wallace, M.S., RAC-Drugs
Director of clinical research regulatory affairs
Division of Strategy and Regulatory Affairs
Elizabeth Kissell, MPH, CCRP
Clinical research monitor/FDA program administrator
Division of Strategy and Regulatory Affairs
Katie Landes, CCRC
Clinical research monitor
Division of Strategy and Regulatory Affairs
