The Clinical Research Monitoring Service will be provided for certain investigator-held IND/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 DSMB or an auditor:

Role DSMB Study Monitor Human Subjects Auditor
Purpose Subject safety Service for PIs and study teams Institutional oversight
Function 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.
A quality control function conducted continuously throughout a trial.

Oversees the progress of a trial to ensure that it is conducted, recorded, and reported in accordance with the protocol, GCP, SOPs, and applicable regulatory requirements.

 

An independent, top-down, quality assurance function conducted at one point during the trial.

Examines trial documents and activities to determine whether activities were conducted and data were recorded, analyzed, and accurately reported according to the protocol, GCP, SOPs, and regulatory requirements.

Contact us if you have questions about the Clinical Research Monitoring Service or are interested in utilizing this service.