UAMS Office of Research Regulatory Affairs (ORRA) Monitoring Unit (MU) is responsible for monitoring all UAMS-sponsored Investigator-Initiated Trials (IITs) conducted under an Investigational New Drug Application (IND) or Investigational Device Exemption (IDE).
If the trial requires an IND or IDE, ORRA’s MU will work closely with the Principal Investigator and their staff to ensure monitoring as required by federal regulations (21 CFR 312.56 and 21 CFR 812.40).
As part of Pre-Study Visits (PSVs) and Site-Initiation Visits (SIVs), MU will provide necessary education / training on a wide variety of topics (e.g., Good Documentation Practice [GDocP], Good Clinical Practice [GCP], maintenance of essential records, use of electronic data capture systems, documentation of adverse events [AEs] and deviations, investigator responsibilities, and investigational product [IP] use / accountability), assure that all regulatory documentation has been compiled and collected, all details of trial procedures have been addressed, and a plan is in place for procurement of supplies and investigational agent(s). Enrollment should not begin until after monitors conduct SIV.
Interim Monitoring Visits (IMVs) will be conducted throughout the trial to verify that the rights and well-being of human participants are protected, the reported trial data are accurate, complete and verifiable from source documents, and the conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable regulatory requirement(s).
Close-Out Visits (COVs) will be conducted after all research-related interventions and interactions with participants are complete and no further enrollment is planned, all data have been collected (no outstanding queries) and analysis of identifiable data are complete. A COV is conducted to ensure that all clinical trial-related activities are appropriately reconciled, recorded, reported and maintained in accordance with the protocol, SOPs, GCP and applicable regulatory requirements. IRB closure should not be submitted until after monitors conduct COV.
Our monitors are also available to assist with CRF development, organizing the regulatory binder and staff training (or re-training) on a case-by-case / as-needed basis.
Contact the ORRA Monitoring Unit at ORRAMonitoringUnit@uams.edu.
Staff Contacts
- Laura Adkins, MAP, CCRP, CCRA, AdvCRS
Director of ORRA
LLAdkins@uams.edu - Cesiley Trevino, MSHP, CCRP, AdvCRS
Clinical Research Monitoring Manager
CTrevino@uams.edu - Crystal Smith, MSW, MA, CRS
Clinical Research Monitoring Specialist
CSmithb2a5@uams.edu - Ashley Clark, MPH, CHES
Clinical Research Monitoring Specialist
ABoureimamorou@uams.edu