ORRA’s Monitoring Unit (MU) provides the following services.
Pre-Study Visits
Prior to initiation, MU will conduct a Pre-Study Visit (PSV) to determine if the investigator and site are equipped to conduct the trial per the approved protocol. During this visit, MU 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 trial will be discussed.
Before the Study
MU will assist the investigator and their team in preparing the essential records (e.g., source documents, case report forms [CRFs], drug/device accountability logs) needed to conduct and track the progress of the trial. If necessary, MU can assist the coordinator with set up of regulatory files/binder.
You are encouraged to contact the UAMS Office of Research Compliance to request a New Investigation Consult and Education (NICE) Review.
Site Initiation Visits
When ready to begin enrolling, MU will work with the investigator and their staff to schedule an Site Initiation Visit (SIV) during which monitors will educate 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, CRFs and source documentation requirements, adverse events (AEs), deviations/violations, monitoring procedures and drug/device accountability and storage.
Interim Monitoring Visits
After trial initiation, MU will schedule Interim Monitoring Visits (IMVs) according to the monitoring plan to review participant activity, data collection, regulatory binders, and drug/device accountability. These monitoring visits serve to ensure the rights, safety and well-being of participants, reliability of data and compliance with protocol and applicable regulations.
After reviewing participant (e.g., medical records, progress notes, source documents, electronic data capture modules, logs, etc.) and regulatory files, MU will compile findings and issue a formal letter with details, including items to be addressed by the research staff.
During the Study
ORRA MU works closely with ORRA’s Regulatory Unit (RU) to assist the research team with protocol amendments, consent form changes, or CRF changes, as needed.
ORRA’s MU can also assist with re-training / continuing education on a variety of topics, if necessary.
Close-Out Visits
At the end of the trial, MU will conduct a Close-Out Visit (COV) to verify that all data has been collected and monitored, all queries have been resolved and copies of documents have been obtained. MU will also perform final drug/device accountability and review all regulatory documents to ensure the file is complete.
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.