Skip to main content

The CTO provides principal investigators with well-trained, area expert, clinical research professionals while supporting trials that are investigator-initiated, federally sponsored by the National Cancer Institute or industry sponsored from concept through activation to close-out. Clinical trials should be conducted in accordance with the ethical principles originating in the Declaration of Helsinki and consistent with Good Clinical Practices and the applicable regulatory requirements. Investigators and staff are required to be trained in Good Clinical Practices, the CITI Biomedical Human Subject Protection, and HIPAA compliance.

CTO staff are additionally trained in having a good understanding of state and federal regulations, guidelines, and certification requirements, including IRB, conflict of interest disclosure, and the FDA regulations and guidelines for the conduct of human clinical research. The broad knowledge of the CTO staff enables investigators to have a strong support system for clinical research conduct.

Principal Investigators

The HCI CTO is committed to helping our principal investigators (PI) have a thorough understanding of investigator responsibilities, such as proper informed consent procedures, eligibility criteria requirements, and adverse event reporting and regulatory requirements. All new CTO investigators are required to complete several local and federal clinical research training modules, and they also receive personalized PI training with an introduction to CTO support directly from the CTO Medical Director.

Principal Investigator Role & Responsibilities

Oversee training and delegation of qualified research staff for the protocol

  • Regularly meet with the study team (recommend weekly) to review patients, trials and document oversight
  • Oversee the participant recruitment process
  • Oversee study procedure compliance
  • Report adverse events within protocol guidelines and timeframes
  • Review source data and case report forms (CRFs)
  • Ensure timely resolution to data queries
  • Adhere to FDA Form 1572- Statement of Investigator - By signing this form, the investigator enters into a legally binding contract with the FDA.

CTO Trial Activation Support

  • Negotiate and execute Confidential Disclosure Agreements (CDA) and Clinical Trial Agreements (CTA), also known as contracts
  • Coordinate pre-site selection visits/site qualification and site initiation visits
  • Develop and negotiate trial budgets
  • Complete regulatory application preparation to all necessary committees:
    • HCI CTO Feasibility Administrative Review Committee (FAR)
    • HCI Protocol Review Monitoring Committee (PRMC)
    • U of U Institutional Review Board (IRB) or Single/Commercial IRB
    • U of U Radiation Safety Committee
    • U of U Institutional Biosafety Committee (IBC)

CTO Trial Duration Support

  • Provide trained clinical research coordination support to support participant recruitment, enrollment, and protocol coordination
  • Provide trained clinical data management for data entry
  • Provide oversight and coordination for study monitoring and auditing
  • Maintain regulatory oversight, including IRB submissions, regulatory binder maintenance, appropriate regulatory reporting for unanticipated problems and adverse events
  • Maintain financial oversight post-award, manage accounts receivables and renegotiate budgets
  • Manage specimen acquisition and shipping per protocol
  • With the HCI Research Compliance Office, coordinate and oversee all aspects of an FDA inspection

Investigator Initiated Trials

During the Planning/Selection Process

  • Facilitate protocol design
  • Set up processes to refine study quality and improve timelines
  • Negotiate Confidential Disclosure Agreements (CDA), Clinical Trial/Study Agreements (CTA/CSA)
  • Develop and negotiate study budgets
  • Conduct regulatory oversight, including FDA IND/IDE submissions
  • Provide internal quality assurance and monitoring for full compliance
  • Plan and conduct investigator meetings and study staff training
  • Design and implement recruitment and retention strategies

During the Study

  • Provide research staffing to meet all study needs
  • Conduct regulatory oversight, including IRB submissions, regulatory binder maintenance, and FDA IND/IDE reports
  • Provide internal quality assurance and monitoring for full compliance
  • Monitor financial performance and renegotiate budgets
  • Assess and promptly resolve any study-related operating or regulatory issues and queries
  • Assist with and coordinate FDA and sponsor audits