Study Monitoring

The services we provide include:

Site Pre-qualification Visits – If you are conducting a multi-site trial, we can assist you in ensuring the sites you are considering have the proper qualifications, subject population, and necessary resources needed to successfully participate in your research study. We will travel to the site and report our recommendations to the PI and Sponsor representative. (*Note: All travel expenses incurred are the responsibility of the investigator.)

Before the Trial – We will assist the investigator in preparing the essential documents that will be needed to conduct the trial. These include source documentation flow sheets, Case Report Forms (CRFs), drug accountability forms, and other logs needed to track the progress of the study. We will assist the coordinator with setting up their regulatory files for this study.  We also encourage you to contact the UAMS Office of Research Compliance to request a NICE Review.

Site Initiation Visits – When you are ready to begin enrolling, we will work with the investigator and their staff to help get the trial started by conducting a Site Initiation Visit . We will assist in educating the members of the research team in the protocol-specific details. This includes protocol review, investigator responsibilities, informed consent process, regulatory documents, source documentation requirements, drug accountability and storage, and case report form completion.

Interim Monitoring Visits – Once your trial starts, we will schedule monitoring visits according to the monitoring plan to review data collection, regulatory binders, and drug/device accountability. These monitoring visits help the investigator identify problem areas with the study. We are not auditors. Our goal is not be punitive, but supportive and ensure good data. We will spend 1-2 days reviewing the records and, at the end of each visit, we will meet with the investigator and/or their staff for a few minutes to relay what we found during the visit. A formal letter with details of the findings will be issued soon after the visit.

During Trial – The monitoring unit works closely with the regulatory unit and will assist the research team with any protocol amendments, consent form changes, or case report form changes that are needed. We can also assist in correcting any problems with the study through education of the study staff.

Closeout Visit – At the end of your study, we will conduct a closeout monitoring visit to verify all data has been collected. We will perform final drug/device accountability review all regulatory documents to ensure the file is complete in the event of an audit.

Audit Preparation – Should the study be audited by an internal auditor or the FDA, we can assist in making sure the site is prepared for that audit.