The Monitoring Process
Types of Monitoring Visits
- Routine/Random Monitoring Visits: routine reviews conducted as part of UTMB's human research protection program.
- Directed/For Cause Monitoring Visits: high-priority reviews conducted in response to concern raised by IRB/EC, sponsor, and/or anonymous report regarding potential non-compliance
- Rotational Monitoring Visits: reviews conducted every three (3) to six (6) months in areas, departments and/or specific research protocols that are considered to be moderate to high risk, those that require additional training and guidance, or have had repeated non-compliant events.
- Self-Initiated Monitoring Visits: reviews conducted in response to a request from a principal investigator.
Protocol Selection for Routine/Random Visits
How is a protocol selected for a monitoring visit? All UTMB human subjects research studies are subject to review including those sponsored by the National Institutes of Health (NIH), the pharmaceutical industry, or internally through university departments/divisions. However, some studies may receive more attention based upon the degree of outside oversight, funding source, experience of the Principal Investigator (PI) and staff with UTMB research policies and procedures, relative level of risk to patients, etc. A more complete listing of perceived risk areas is given below.
Areas of Risk
The HSRMP may take the following factors into consideration when selecting studies for review:
- Phase I studies
- Investigator initiated protocols (e.g. IND/IDE held by PIs)
- Degree of risk to the subject, complexity and length of study
- Vulnerable subject populations and consent waivers
- Protocols with high or rapid enrollment
- Protocols with tissue banking or genetic testing
- Protocols with a conflict of interest (COI) management plan
- Reported/unreported adverse events
- Concerns during or after FDA or other regulatory agency inspections
- Administrative problems with study documentation
- Source of funding
Principal Investigator and Research Staff
The PI and research staff are responsible for ensuring that all essential documents are available to the QA for review. These documents can be provided electronically or in paper form (research files or binders). All paper or electronic documents must be made available to the QA. Please coordinate with your QA about what documents will be necessary for a successful monitoring visit.
Items to be Reviewed
Some of the items subject to review by the QA include, but are not limited to, the following:
- IRB membership list/roster and regulatory documentation
- IRB correspondence (submitted protocol and amendments or changes, approval information, progress reports, renewals, etc.)
- Informed consent documentation, processes, and information
- Research Subject Eligibility verification with Source Documentation, Case Report Forms (CRFs)
- Outcome/Response documentation
- Adverse Events, Unexpected Problems with Source Documentation/CRFs
- Data quality and integrity
- Adherence to written procedures, standard operating procedures (SOPs), IRB policies, UTMB policies and procedures, as well as federal and state laws and guidance
- Investigational Product records if applicable
- Site signature list, monitoring logs, and delegation of authority log
- Other study related documentation, as necessary
Evaluation of the study may include appropriate reporting of deviations, violations, and required adverse events. Elements of review may change over time as deemed necessary to adequately assess the quality of the research process. In order to assess compliance, the OIC staff will document and review all documentation necessary to complete the type of review being performed.
Review Process and Timeline
- Audit Notification and Entrance Interview (Routine Audit-2 week notice)
- Monitoring Visit (~3-7+days)
- Schedule monitoring findings meeting (~7 days)
- Exit Interview (Findings meeting to discuss final report) (~1-2 hours)
- PI Response (Submitted in 2 weeks to OIC)
- Protocol Summary for IRB review (~7 days)
Following the monitoring visit a preliminary monitoring report will be completed and delivered to the PI. At the PI's request, the QA will meet with the PI and research team to discuss findings from the review. This report will list both positive findings as well as recommendations for improvement, such as:
- Identifying problematic areas and presenting solutions for correcting non-compliance through education, thereby improving research compliance and preventing situations that might increase risks to research subjects or lead to regulatory citations;
- Working with the research community to adopt best practices and facilitating research;
- Offering supplemental hands-on educational and regulatory training to researchers and staff;
- Offering recommendations to the research community to improve its clinical research infrastructure;
- Requiring the PI to present a written response to the OIC with self reports to the IRB for non-compliance and implemented corrective action plans. Based upon the PI's response the OIC will issue a report to the IRB and other entities;
- The IRB will review all monitoring findings and will respond to the PI and other entities, as required.
The PI will thereafter have two (2) weeks in which to respond in writing to the preliminary findings of the QA. Thereafter, the QA will issue a final report to the PI, incorporating any changes or updates made as appropriate. Should the research team fail to respond within the specified time frame the review findings along with the preliminary review summary will be sent to the IRB and other entities without the PI's response. It is therefore very important that the PIs and/or their designated research team members timely respond to the findings in order to ensure that their comments and/or concerns are included and addressed. Communication of the outcome of IRB review will be provided directly from the IRB to the PI.