We provide the following services.
Pre-Study Visits (PSVs)
Prior to study initiation, we will conduct a Pre-Study Visit to determine if the investigator and site are equipped to conduct the study per the approved protocol. During this visit, we will ensure that all procedures can be performed and data collected as written. Logistics, timing, staffing, resources, and other topics relating to successful performance of the study will be discussed.
Before the Study
We will assist the study team in preparing the essential documents that will be needed to conduct the trial. These include source documentation, case report forms, drug/device 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 New Investigation Consult and Education Review.
Site Initiation Visits (SIVs)
When you are ready to begin enrolling, we will work with the investigator and their staff to help get the study 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 a presentation with information on investigator responsibilities, regulatory documents/binder, review of protocol, informed consent process and documentation, case report forms and source documentation requirements, adverse events, deviations/violations, monitoring procedures and drug/device accountability and storage.
Interim Monitoring Visits
Once your study starts, we will schedule monitoring visits according to the monitoring plan to review subject activity, data collection, regulatory binders, and drug/device accountability. These monitoring visits help the investigator identify problem areas with the study and ensure compliance with regulations.
We will spend one to two 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.
We are not auditors. Our goal is not be punitive, but supportive and ensure quality data.
During the Study
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.
Close Out Visits (COVs)
At the end of your study, we will conduct a close out monitoring visit to verify that all data has been collected and monitored, all queries have been resolved and copies of documents have been obtained. We will also perform final drug/device accountability and review all regulatory documents to ensure the file is complete.
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.