Purpose
The purpose of clinical trial monitoring is to verify:
- The rights and well-being of human subjects are protected.
- The reported trial data are accurate, complete, and verifiable from source documents.
- The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirements such as the FDA, state laws, and University of Miami policies and procedures.
Monitoring Program
CRORS provides monitoring for UMMSoM investigator-initiated FDA-regulated (IND/IDE) clinical trials. CRORS may also provide monitoring services for IND/IDE exempt interventional drug or device studies as requested by a department or investigator and as workload allows.
CRORS should be contacted by the Sponsor-Investigator/ Principal Investigator / study team prior to IRB/FDA submission. During the initial consultation, CRORS will discuss the study protocol with the Sponsor-Investigator in order to develop a risk-based monitoring plan and also determine the fee to be charged for the monitoring services provided.
Risk Based Monitoring – A risk-based approach will be taken for all studies monitored by CRORS. For each study, the risk level will be assessed. Risk factors such as objective(s), purpose, design, complexity, blinding, participant population, number of trial participants, investigational product (IP), current knowledge of the IP safety profile and endpoint will be assessed. According to the determined level of risk, an individualized monitoring plan will be created for each study.
During the monitoring process, CRORS will assist the Sponsor-Investigator by:
- Review of participant informed consent document and process
- Review of subject eligibility for the trial
- Review of safety i.e. adverse event reporting
- Review of compliance with the protocol, regulations and institutional policies
- Targeted review (based on the monitoring plan) of the accuracy, completeness and consistency of reported trial data against the source records and other trial-related records and whether these were reported in a timely manner
- Ensuring that corrections, additions or deletions to case report forms (CRFs) are made as appropriate, dated, explained (if necessary).
- Providing customized training to the study team based on any issues found during the monitoring visit
- Confirming that the investigator is maintaining the essential records
- Review of investigational product accountability
- Reporting what was reviewed, significant findings, conclusions, actions required to the Principal-Investigator and/or Sponsor-Investigator
- Follow-up with study team to resolve issues and action items.