CRORS is a quality improvement program that provides regulatory support and assistance to the University clinical research community, along with Quality Control (QC) services (monitoring). The monitoring group was established in Sept. 2011 to conduct the following:
- Initiate monitoring of Investigator-Initiated IND studies that were not previously monitored
- Develop monitoring plans to existing and new IND studies
- Conduct risk-based monitoring for Investigator-Initiated IND/IDE studies.
monitor – An individual designated by a sponsor or contract research organization (CRO) to oversee the progress of an investigation. May be an employee of or consultant to the sponsor, or an employee of or consultant to a CRO.
monitoring – The act of overseeing the progress of a clinical trial, and ensuring that it is conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). E6 ICH-GCP 1.38 (PDF)
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.
CRORS provides monitoring for IND/IDE and federally funded studies. Ideally, CRORS will be contacted by the Sponsor-Investigator/PI/study team prior to IRB/FDA submission. There is a fee for monitoring.
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 investigator held IND or IDE (“Sponsor-Investigator”), study medication/device, study related procedures, study population, etc. will be assessed. According to the determined level of risk, an individualized monitoring plan will be created for each study.
- Oversee the ongoing progress of a clinical trial.
- Source document verification for subject according to risk based monitoring plan.
- Ensuring that the trial is conducted, recorded and reported in accordance with Protocol, SOPs, GCPs, and all applicable regulatory requirements.
- Monitoring report is created. NO written response is required.
- Monitoring activities are subject to FDA audits.
- Customized training.
- Updates on Federal regulations and guidances.
- Ensure the study team follows UM policies and procedures and departmental Standard Operating Procedures.
- Exit meetings with the Principal Investigator and study team.