Clinical Trials (CTO) Services

Study Coordination

  1. Assist with the timely opening and implementation of clinical trials
  2. Process and reporting of safety reports
  3. Assist with protocol review and data safety monitoring committees
  4. Assist with ClinicalTrials.gov reporting

Regulatory

  1. Assure all local and federal governmental requirements are met
  2. Provide support for all Investigational Review Board submissions and amendments
  3. Assist with credentialing of all research personnel involved in clinical trials

Administrative/Fiscal

  1. Provide administrative support for the CTO
  2. Provide oversight for all financial matters of the CTO

Protocol Development

  1. Provide support for the activation, implementation, and monitoring of all NCI-sponsored, Investigator Initiated, and Industry sponsored trials
  2. Assist with Protocol Review and Monitoring Committee functions

Education and Training

  1. Provide education and training for all clinical trials research staff and providers

Clinical Trials Data Management

  1. Provide support for the collection, storage, and reporting of all research information generated at the UH Cancer Center and to make sure it meets NCI requirements

Biospecimen and Drug Management

  1. Provide support for the safe and timely collection, storage, and disposition of drugs and biological material