Clinical Trials Management

Since 2006, the University of Arkansas for Medical Sciences (UAMS) has been developing the Comprehensive Research Informatics Suite (CRIS), formerly known as the Clinical Trials Management Suite.  CRIS is a comprehensive set of open source software tools for electronic management of clinical trials and associated data.  All components of the UAMS CRIS are web based, enabling sharing and integration of clinical research information for single and multi-site trials. All applications are integrated into a portal that allows single point of access with a registered UAMS username and password. All CRIS applications reside on a cluster server with failover capability behind the UAMS firewall, and thus have the benefit of high security, fire protection and routine backup.

The CRIS includes applications for the following:

  • Subject Registration: The subject registration application, C3PR, enables efficient and streamlined registration of participants into clinical trials. It captures the consent signed date, eligibility criteria, screen failures, stratification, randomization and amendments. Clinical workflows are enabled by both subject- and study-centric views into the registration process. It also enables multi-site clinical trials where registration information is entered locally at affiliate sites and completed by the coordinating site. Registration data also can be pulled from UAMS Medical Center to minimize manual data entry and enhance data quality.
  • Study Calendar Management: Patient Study Calendar (PSC) is a standards-compliant application for creating and managing subject activities and study calendars.  It provides the ability to create and edit study calendar templates, generate and view prospective calendars of subject activities, track activities as they occur, and manage subject calendars as they change during a study. PSC accommodates all types of clinical studies and facilitates management of the screening process, registration, active monitoring, and long-term follow-up.
  • Free Text Extraction: The caTIES application enables de-identification and automated coding of free-text structured reports.  It provides researchers with the ability to query, browse and acquire annotated tissue data and physical material across a network.
  • Participant Recruitment: UAMS TrialSearch is an application that allows users to search actively enrolling protocols at UAMS based on disease, investigator name, treatment, sponsor or a key word.
  • Tracking Regulatory Events: UAMS EventTracker is an application for tracking key regulatory dates such as IRB submissions and approvals.
  • Reporting: A number of reports have been created to easily retrieve data such as enrollment by physician and staff workload.
  • Electronic Data Capture: The CRIS also integrates OpenClinica & LimeSurvey for electronic data capture.