University of Pittsburgh Cancer Institute (UPCI)

Services

CRS facilitates the following:

  1. Assistance to the Principal Investigator (PI) in the development of clinical research studies:
    • Provides guidelines and format requirements for clinical research studies.
    • Serves as the central intake and distribution point for all cancer-related clinical research studies (NCI sponsored, UPCI-initiated, pharmaceutical/biotech, and cooperative group), and ensures that all components of each study are completed prior to copying, collating, and distributing study protocols.
    • Prepares agenda and distributes copies of new, modified, and renewal protocols for cancer-related clinical research studies at PRC meetings.
    • Prepares protocol summaries and consent forms in a format in accordance with the Office for Human Research Protection (OHRP), Food and Drug Administration (FDA), and University of Pittsburgh IRB. These documents, in draft form, are submitted to the PI for final review.
    • Maintains a master regulatory file for each clinical research study that includes all communications, amendments, Serious Adverse Events (SAE) reports, and notices sent for activation, suspension, closure, and termination, as well as other relevant study correspondence.
  2. Preparation of research studies for presentation at the UPCI's Protocol Review Committee (PRC)
    • Ensures the review of the protocol by the disease-site program leader and assists the PI in identifying the CRS resources to be utilized and funding available (e.g., Clinical and Translational Research Centers, etc.) for the newly proposed study. The review must occur prior to submission of the study to the PRC. The PRC utilizes a standardized checklist that provides pertinent information for the PRC reviewers. The checklist must accompany the study and lists all resources that would be utilized, as well as documentation that the disease program director is aware of and approves the use of the resource.
    • Documents protocol review and recommendations by the PRC. PRC's review is forwarded to each PI. The CRS staff assists the PI in making the requested modifications in the study protocol and assists with response to the PRC comments/questions.
    • Prepares PRC-approved studies for submission to the University IRB(s) for review and approval by developing necessary IRB documents such as a 7-10 page IRB research protocol summary and a subject consent form which are consistent with IRB policies and procedures.
  3. Preparation of research studies for the University Institutional Review Boards (IRBs)
    • Maintains a database containing information on all research trials including investigator-initiated, peer-review funded and cooperative group, and pharmaceutical/biotech-sponsored clinical research protocols. The database identifies where each study is in the approval process.
    • Provides timely submission of the study and all supporting documents to the appropriate IRB(s).
    • Amends all clinical research studies in a timely manner and submits to the IRB(s).
    • Informs investigators of the approval status of each clinical research study along with a report of the progress of all ongoing research trials.
    • Prepares study renewal forms and study progress reports for review by the appropriate IRB(s) in compliance with their guidelines.
    • Submits ongoing correspondence regarding the study status (i.e. study closure, suspension, and closed to accruals).
    • Submits all Data Safety Monitoring information received from sponsors on multicenter trials and from the UPCI DSMC to the IRB.
    • Submits all serious adverse events (SAE) reports to the University IRB as per their guidelines. Updates consent forms based on new risks identified or changes in the frequency of risks.
    • Prepares monthly reports on study progress including accruals, adverse events, protocol deviations, and death while on study for the DSMC.
    • Facilitates communications between the IRB Executive Committee and the UPCI investigators by meeting regularly with the IRB Chairman and staff to review processes and problems in order to ensure rapid and effective resolution so as to maintain compliance of the federal regulations.
  4. Preparation of research studies for the FDA, including investigator-held IND submissions; NCI/CTEP; and/or other research sponsors
  5. Implementation of newly opened clinical research studies
    • Clinical research coordinators (CRCs) and oncology registrars are assigned to specific disease-site or modality programs, and each clinical research study is assigned to a designated CRC. CRCs collaborate with a multitude of disciplines and support facilities in order to ensure effective implementation of each study. CRCs are responsible for facilitating and enabling communication among all departments, and for maintaining current clinical research and patient information on a daily basis. Oncology registrars are assigned to assist the CRCs with data collection, data entry, and quality control.
    • A Central RN Clinical Trials Auditor systematically conducts internal audits of clinical research records on a twice-monthly basis. In addition, the University's Research Conduct and Compliance Office (RCCO) conducts audits on random and/or selected protocols throughout the year and also reviews the consent process between investigator and subjects.
  6. Review of financial and insurance coverage for subjects participating in clinical research studies
  7. Monitoring of accrual of subjects for clinical research studies, by study, Program, or disease-site group, and by individual investigators, with distribution regularly of reports on accruals relative to targets
    • Screens eligible patients who have signed the HIPAA consent, and documents fulfillment of all eligibility criteria, and registration by CRS staff.
    • Lists all approved and active trials on the UPMC CancerCenter clinical trials website and in the Clinical Trials Report publication, to enhance accrual to clinical trials at the Hillman Cancer Center and the community-based UPMC CancerCenter network.
  8. Coordination of clinical research studies at all UPMC CancerCenter sites in regard to safety, regulatory compliance, and other requirements for study implementation
  9. Documentation/reporting of adverse reactions (serious and non-serious) to all appropriate regulatory committees, (e.g., IRB, FDA, NIH, OBA, NCI, UPMC DSMC, etc.)
  10. Audit of trials and coordination of sponsor site visits with implementation of any corrective measures
  11. Collection and entry of data related to response to treatment, disease recurrence, and survival status, in close cooperation with Cancer Bioinformatics Services and the UPCI/UPMC Cancer Registry