The Clinical Research Monitoring Service will be provided for certain investigator-held Investigational New Drug (IND)/Investigational Drug Exemption (IDE) studies and is available for other investigator-initiated trials.
Additional monitoring requests will be evaluated by the Clinical Research Monitoring Program staff. Sponsor-Investigators (investigators who hold an IND/IDE) have the responsibility to ensure proper monitoring of the investigation and select a monitor qualified by training and experience to monitor the progress of the investigation.
The role and purpose of a monitor, while related, is different from that of a Data and Safety Monitoring Board (DSMB) or an auditor:
|Role||Data and Safety Monitoring Board (DSMB)||Study Monitor||Human Subjects Auditor|
|Purpose||• Subject safety, study conduct and progress.
• An independent and external group of experts appointed by the sponsor/sponsor-investigator.
|• Oversees the progress of a clinical trial at all stages.
• In-depth routine evaluation.
|• Institutional oversight.
• Snapshot in time of a subset of participants.
|• Periodically reviews and evaluates accumulated data from a clinical trial for subject safety, study conduct and progress, and as necessary, efficacy.
• Makes recommendations to the sponsor regarding the continuation, modification, or termination of the trial.
|• “The act of overseeing the progress of a clinical trial, and of 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)” [ICH 1.28].||• “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s)” [ICH 1.6].|
Contact us if you have questions about the Clinical Research Monitoring Service or are interested in utilizing this service.