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Research Orientation to SCCA

Research Orientation to SCCA. The SCCA brings together the outstanding adult and pediatric oncology patient care services of three world-renowned institutions: Fred Hutchinson Cancer Research Center University of Washington Seattle Children’s. What is the SCCA?.

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Research Orientation to SCCA

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  1. Research Orientation to SCCA

  2. The SCCA brings together the outstanding adult and pediatric oncology patient care services of three world-renowned institutions: • Fred Hutchinson Cancer Research Center • University of Washington • Seattle Children’s What is the SCCA?

  3. Relationship of SCCA, FHCRC, UW and SCH

  4. Mission Statement: • Provide state of the art, patient and family centered care; • Support the conduct of cancer clinical research and education; • Enhance access to improved cancer interventions; • Advance the standard of cancer care regionally and beyond. Vision Statement: • To lead the world in translating scientific discovery into the prevention, diagnosis, treatment, and cure of cancer. Why is SCCA here?

  5. The Role of the SCCA in Research: • The SCCA is a site of practice for clinical research. • SCCA staff support the conduct of clinical research. Research at the SCCA

  6. The SCCA’s Research Responsibility: • To ensure that the SCCA is a “safe and compliant environment” for the conduct of human subject research. • This is accomplished through our Human Research Participant Protection Program (HRPPP). Research at the SCCA

  7. SCCA’s Human Research Participant Protection Program (HRPPP) is the system that protects the rights and welfare of individuals who participate in research. SCCA’s HRPPP Goals: • To protect participants involved in clinical trials research; • To facilitate clinical trial and research implementation; • To assure compliance with federal regulations and other legal requirements. Human Research Participant Protection Program

  8. The SCCA does not financially sponsor its own research, however, we support research as part of our relationship with our partner institutions. The SCCA has agreements with the following Institutional Review Boards (IRBs): FHCRC, UW, SCH, SMC, & WIRB. Relationship between SCCA and IRBs

  9. The Research Implementation Office has two primary functions: • RIO manages our Human Subject Research Participant Protection Program (HRPPP), which is federally mandated for institutions involved in clinical research. • RIO facilitates the implementation of new research studies into the clinic and inpatient oncology environments to ensure that all operational issues are addressed prior to study participant accrual occurring. Research Implementation Office (RIO)

  10. Primary Investigator (PI): The PI has ultimate responsibility for the research. The lead PI is responsible for all aspects of the protocol development and conduct. Research Staff: Responsible for the day-to-day operations of the research study including: site preparation, participant screening and recruitment, reviewing records and abstracting data, completing case reports (CRFs), SAE reports, budgeting, timely submission of fee sheets/forms. Research Roles & Responsibilities

  11. Principal Investigator (PI) or sponsor has an idea; • Investigator/sponsor works with co-investigators, administration, sponsor and Research Consortium to develop the protocol and consent documents. The Path of a Clinical Trial

  12. Protocol and related material submitted for: • Scientific review (e.g., Scientific Review Committee [SRC]); • Safety review (e.g., Institutional Biosafety Committee [IBC] or Radiation Safety Committee [RSC]); • Other peer-reviews (e.g., Clinical Investigator Meeting [CIM]). The Path of a Clinical Trial

  13. Investigator determines what components of clinical trial are routine care for that disease and what portions of the clinical trial are non-routine care or solely to support study data. Path of a Clinical Trial

  14. Protocol submitted to IRB for review and approval: • FHCRC • UW • Seattle Children’s • Swedish MC • Western IRB The Path of a Clinical Trial

  15. Protocol submitted to SCCA Research Implementation Office (RIO) for review of implementation issues. Path of a Clinical Trial

  16. The following SCCA committees are involved in the protocol/clinical trial implementation and operation process: • BMT Protocol Implementation (PIM) • Clinical Trial Implementation (CTI) Safety reviews: • Institutional Biosafety Committee (IBC)* • Radiation Safety Committee (RSC) *Facilitated by RIO Implementation Process

  17. Multidisciplinary review of clinical trials, research protocols and consent forms; • Each group has a medical advisor to assist with medical practice issues/concerns (e.g., std of care vs. research); • Review determines if the SCCA is equipped and staffed to support the research & identifies any gaps prior to initiation of study; Implementation Review Summary

  18. Ensure the informed consent process is designed, approved and documented in participant’s medical record; • Provide pricing for research-only activity at SCCA; • Obtain confirmation that all outstanding issues have been appropriately addressed prior to accrual. Implementation Review Summary

  19. BMT Protocol Pathway

  20. Oncology Protocol Pathway

  21. Study staff must be familiar with the protocol they are representing, especially the areas where the research intersects with clinic activity; • The questions and discussion are generally around how to make the research “fit” in the clinic processes What is expected of Study Staff at CTI/PIM?

  22. Examples of questions from CTI/PIM: • What is the target population for this study? Are there any special needs for this group? • Has this type of study been done here before? • What clinical areas will be impacted? OP only or OP and IP? • Will non-SCCA medical equipment be brought to the clinic and used? • Will there be special participant registration or scheduling needs? • Who will do the consenting? When will it occur? • Are there any tests/services that should not be charged to the patient? Does the study need research pricing? • What type of staff education is needed and for which staff? • Will protocol-specific pre-printed orders be created and used? What is expected of Study Staff at CTI/PIM?

  23. Depts./Services Represented at Research Implementation Meetings

  24. Check out our web page for policies, procedures, forms (ex: CTPI form to obtain research pricing) and other research staff resources: http://www.seattlecca.org/Research-Staff-Resources.cfm Or contact us by email at: RIO@seattlecca.org For more information:

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