Clinical Trials Office

The mission of the Clinical Trials Office (CTO, Clinical Protocol and Data Management Program –  CPDM) is to provide infrastructure support for clinical trials conducted at and by the University of Arizona Cancer Center (UACC). Units within the CPDM include clinical trial budgeting, regulatory support, investigator-initiated trial (IIT) protocol development, cooperative group administration, quality assurance/quality control, Data Safety Monitoring Board coordination, clinical research operations with both clinical research coordinators and research nurses, and clinical research informatics. The purpose of the CTO unit is to partner with UACC investigators to provide experienced and consistent human and material resources to support the institution’s clinical research mission, while ensuring that research is conducted in an ethical manner in compliance with applicable rules and regulations.

The UACC CTO unit oversees industry-sponsored, institutionally sponsored, externally peer reviewed, and national group interventional clinical trials. The UACC is a member of several cooperative groups, including the Southwest Oncology Group (SWOG; full member), NRG Oncology (Breast Alliance, Radiation Therapy, and Gynecologic oncology; affiliate member) and Children's Oncology Group (COG; affiliate member). The majority of faculty members that the CTO unit serves are members of the section of Hematology and Oncology, with other represented departments being: Senior Vice President for Research office, Nutritional Sciences, Pediatrics, Obstetrics and Gynecology, Surgery, Radiation Oncology, and Psychiatry. At the UACC, research groups are split by disease site of interest. Disease teams who utilize the CTO unit include:

  • BMT/Leukemia
  • Breast
  • Gastrointestinal
  • Genitourinary
  • Gynecologic
  • Lung
  • Lymphoma
  • Pediatric oncology
  • Phase I; undefined/all sites
  • Sarcoma
  • Melanoma
  • Supportive Oncology

The CTO unit partners closely with the Protocol Review and Monitoring System (PRMS) to ensure compliance and efficiency of the scientific review process during study start-up and throughout the activation of the protocol. Unit services of CTO include:

  • Investigator-Initiated Trial (IIT) Development

    • Provide scientific writing and regulatory expertise to develop a letter of intent (LOI) into an executable clinical trial protocol
    • In partnership with the investigator, fully develop the scientific question of interest
    • Ensure that a clinical protocol includes all necessary sections for regulatory compliance (PRMS, IRB, DSMB, FDA GCP)
    • Collaboration with other CTO units to participate in addressing SRC, IRB, DSMB and other committee queries
    • Assess the need for a protocol IND (FDA submission), prepare initial IND submission and maintenance of the IND, facilitate response to IND/FDA Review queries and assist in the prioritization of protocols in accordance with UACC guidelines
  • Data Safety Monitoring  Committee/Quality Assurance and Quality Control (QA/QC)

    • Monitoring of regulatory and clinical information for investigator-initiated interventional trials that are sponsored by the University of Arizona Cancer Center, including prevention intervention, supportive care intervention, and therapeutic intervention. Studies may be institutionally funded, externally peer-reviewed and funded, or funded through some other non-industry mechanism (e.g. non-profit organization).
    • Maintain the NCI-, IRB- and DSMB-approved data and safety monitoring plans
    • Coordinate activities of the Data and Safety Monitoring Board (DSMB) and communicate findings to investigators
  • Budget

    • Building and negotiation of new clinical trial budgets
    • Routing of the clinical trial agreement (CTA, contract)
    • Medicare Coverage Analysis (MCA)
    • Assisting investigators develop budgets for investigator-initiated trials
    • Post-award charge validation
    • Sponsor billing, invoicing, and allocation of incoming funds
  • Regulatory

    • Ensuring that new and ongoing clinical trials have met the regulatory requirements set out by overseeing federal entities and the study sponsor
    • Routing of confidentiality disclosure agreements (CDA)
    • Act, on behalf of the principal investigator, as the primary contact between the regulatory compliance offices/committees and the UACC, including the UACC Scientific Review Committee (SRC), Institutional Review Board (IRB)/Human Subjects Protection Program (HSPP), the Privacy Office, the Conflict of Interest Office, Institutional Biosafety Committee, Medical Radiation Safety Committee, and the University of Arizona Health Network Site Review Authority
    • Interfacing with the study sponsor regarding study start-up and maintenance of study documentation
    • Liaison to the disease team through coordination disease team meetings
    • Prepare initial and ongoing submissions to all regulatory compliance offices, ensuring that submissions and necessary responses are made in accordance with required deadlines and reflect professional standards
    • Timely entry of accurate study related information into OnCore for regulatory and administrative reporting
    • Participation in routine and end of study monitoring by preparing necessary documents for monitors and addressing queries.
  • Operations

    • Provide direct clinical support to research studies
    • Consent support
    • Scheduling research subject visits
    • Research data abstraction
    • Research specimen collection, processing and shipping
    • Addressing monitor queries
    • Research nursing support
  • Clinical Trial Informatics

    • OnCore (clinical trial management system) and Epic (electronic medical record) research builds
    • Case Report Form (CRF) builds within OnCore
    • Education and training on use of OnCore, in coordination with the UACC Informatics Team
  • Cooperative Group administration

    • Research staff liaison with the cooperative group, and along with the Principal Investigator, is the voice of the UACC at the National Cancer Institute (NCI) for cooperative group issues at the UACC
    • Implements the requirements of the national groups and is listed as the Head Clinical Research Coordinator with the national group
    • Maintaining the institutional grant(s) and contract(s) associated with the operation of the cooperative groups
    • Maintaining affiliation agreements with other clinical entities
    • Managing cooperative group membership
    • Disseminating education, travel and funding opportunities
    • Assisting young investigators with application to the young investigator's program and advisement of investigators in the development of new protocols for submission to the cooperative group and Cancer Therapeutic Evaluation Program (CTEP)
  • Clinical trial metrics

    • Efficiency metrics for study activation timelines
    • Staff workload metrics for clinical trial budgeting
    • Accrual metrics for CCSG reporting
    • Clinical trial accrual prediction modeling

Contact information:
Director: Daniel Persky, MD

Administrative Assistant:  Lora Macias
(520) 694-9080

Clinical Research Teams

Additional Information