In the very competitive environment surrounding most granting agencies, grants must have more than good scientific hypotheses and methods to be awarded. There is new emphasis on not only scientific strength, but also on administrative components to ensure that trials will produce the meaningful results.
Third party monitoring
is a key component in demonstrating expertise in trial management and
can greatly improve the quality of results. The purpose of trial
monitoring as defined in ICH GCP is to ensure that:
- The rights and well-being of trial participants are protected,
- The reported trial data are accurate, complete, and verifiable from source documents, and
- The conduct of the trial is in compliance with the currently approved protocol/amendments, with GCP, and with the applicable regulatory requirements.
OCRSS can provide monitoring for studies performed within or outside the University of Louisville. Our monitoring team members have certification through the Association of Clinical Research Professionals (ACRP) and years of experience.
are several ways to approach trial monitoring. The determination of the
approach is based on the protocol, patient population, nature of the
test article, available budget, and discussions with the principal
investigator to determine needs. OCRSS can advise the investigator on
the best approach based on available resources.
The most common types of monitoring are
- Central monitoring
- On-site monitoring
No matter what approach is taken; OCRSS monitors will comply with the following while monitoring a trial:
- University of Louisville Policies
- FDA regulations
- OHRP guidance
- ICH GCP guidance
The following activities may be performed based on the needs identified in the monitoring plan:
- Generating adequate reports for remediation
- Documenting protocol violations and AEs
- Documenting regulatory compliance
- Identifying training needs
- Identifying procedural changes needed