1. Research Orientation to SCCA

2. What is the 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 Confidential

3. Relationship of SCCA, FHCRC, UW and SCH Confidential

4. Why is SCCA here? 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. Confidential

5. Research at the SCCA 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. Confidential

6. Research at the SCCA 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). Confidential

7. Human Research Participant Protection Program 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. Confidential

8. Relationship between SCCA and IRBs 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. Confidential

9. Research Implementation Office (RIO) The Research Implementation Office has two primary functions: 1.RIO manages our Human Subject Research Participant Protection Program (HRPPP), which is federally mandated for institutions involved in clinical research. 2.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. Confidential

10. Research Roles & Responsibilities 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. Confidential

11. The Path of a Clinical Trial 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. Confidential

12. The Path of a Clinical Trial 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]). Confidential

13. Path of a Clinical Trial 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. Confidential

14. The Path of a Clinical Trial Protocol submitted to IRB for review and approval: 1.FHCRC 2.UW 3.Seattle Children’s 4.Swedish MC 5.Western IRB Confidential

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

16. Implementation Process 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 Confidential

17. Implementation Review Summary 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; Confidential

18. Implementation Review Summary 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. Confidential

19. BMT Protocol Pathway Confidential

20. Oncology Protocol Pathway Confidential

21. What is expected of Study Staff at CTI/PIM? 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 Confidential

22. What is expected of Study Staff at CTI/PIM ? 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? Confidential

23. Depts./Services Represented at Research Implementation Meetings Confidential

24. For more information: 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 Confidential