Clinical Trials Office Services

Jessica M.J. Rhee, MD, MS, Medical Director
Kate Bryant-Greenwood, Clinical Manager

CTO services include:

Study Coordination

  1. Regulatory services
  2. Complete new IRB submissions and amendments
  3. Process safety reports
  4. Assist with ClinicaTrials.gov reporting

Fiscal Services

  1. Develop and negotiate budgets and amendments for trials with industry sponsorship
  2. Provide post award support to research staff

Protocol Development

  1. Develop investigator-initiated protocols
  2. Negotiate for novel agents with industry sponsorship

Education and Training of Clinical Trial Staff

  1. Provide regular educational meeting for research staff
  2. Conduct orientation for new hires
  3. Produce clinical research newsletter & email communications

Clinical Research Group Support

  1. Oversee clinical research group flowcharts and webpages
  2. Post trial listing to UH Cancer Center website, Clinicaltrials.gov and NCI CTRP

OnCore Database

  1. Facilitate data collection and reporting of clinical cancer research per NCI requirements
  2. Develop study calendars
  3. Set up user-specific OnCore access and training

Protocol Review and Monitoring System (PRMS)

All cancer-related protocols at University of Hawaiʻi Cancer Center are required to be reviewed by the Protocol Review and Monitoring System, also known as PRMS. Subject enrollment cannot begin until both PRMS and IRB (Institutional Review Board) approvals have been obtained and a Study Activation Notice has been received for that protocol.

Components of the PRMS include:

  1. CRABCommunity Research Advisory Board – aka pre-protocol review and monitoring committee (PRMC) - meets monthly to review feasibility to conduct the trial in a community setting
  2. PRMC – Protocol Review and Monitoring Committee - meets monthly to provide scientific review of trials
  3. DSMC – Data Safety Monitoring Committee - meets quarterly to review safety data of ongoing trials
  4. EPCRS – Early Phase Clinical Research Support - meets as needed to review center-wide investigator initiated early phase trials seeking financial support