The Cancer Clinical Trials and Regulatory Affairs (CCTRA) provides comprehensive support for clinical and translational trials done in cancer. The office coordinates meetings to facilitate trial development and feasibility assessments by the Disease Oriented Committees (DOCs) and Protocol Review and Monitoring Committee (PRMC), and it coordinates all aspects of the research. The office ensures that the research is conducted in compliance with all regulations and with attention to quality.  Quality is established and maintained through routine audits, monitoring visits and a peer review process.

Clinical research is prioritized, conducted and monitored by the Disease Oriented Committees (DOCs) reporting to the Protocol and Review Monitoring Committee (PRMC) and Cancer Institute Director. The CCTRA coordinates and carries out the functional work of these entities.

Services

  • Confidentiality agreement
  • Feasibility assessment
  • Pre-study site visit
  • Obtain/organize all documents
  • Develop/modify consent
  • Submit documents to all committees (IRB, biosafety, etc.)
  • Log events during activation
  • Maintain study documents
  • Build budget
  • Budget approval
  • Negotiate budget
  • Study initiation
  • Delegation log maintenance
  • Study training for staff
  • Publish trial and packet
  • Publish to AR-CRIS
  • Submit for build in Epic
  • Publish trial in Epic
  • Pre-screen subjects
  • Consent
  • Subject registration
  • Conduct trial
  • AE reporting
  • Complete CRF’s
  • Monitoring visits/Audits
  • Clinical billing monitoring
  • Invoicing

The Cancer Clinical Trials and Regulatory Affairs Office office is a resource available to all Cancer Institute investigators. We look forward to talking with you about clinical trials at the Cancer Institute.

For additional information, call (501) 686-8274, or write to us at:

Cancer Clinical Trials and Regulatory Affairs Office
University of Arkansas for Medical Sciences
4301 West Markham #724
Little Rock, AR 72205

View a list of open clinical trials.