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Confidential
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
Relationship of SCCA, FHCRC, UW and SCH
Oncology Care Delivery System
UWMCOP Oncology Services
SCCAOP Oncology Services
Seattle Children’sOP Oncology Services
SC Pediatric IP(38 beds)
UWMC Adult IPSCCA
Adult IP(20 beds)Inpatient
Facilities
OutpatientFacilities
(Adult) (Pediatric)
InfusionClinicRadiationDiagnostic
Procedures (Major/Minor)
InfusionClinicRadiationDiagnostic
Procedures (Minor)
InfusionClinicDiagnostic
Procedures (Major/Minor)
8NE
Confidential
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
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
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
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
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
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
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
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
The Path of a Clinical TrialProtocol 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
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
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
Path of a Clinical Trial
• Protocol submitted to SCCA Research Implementation Office (RIO) for review of implementation issues.
Confidential
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
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
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
BMT Protocol Pathway
Protocol Implementation
Protocol Design
Protocol is submitted to
Research Trials Office.
2 weeks
Scientific Review Committee
Meeting(SRC)2nd & 4thMonday
CRDClinical
Investigators Meeting(CIM)
Tuesdays
Protocol Implementation
Meeting(PIM)
Wednesdays
3 weeks2-3 weeks1 week
PI submits protocol and related documents
to IRB for review.
Institutional Review Boards
(IRB)2nd & 4th
Wednesday
0-30 days
IRB reviews and approves
protocol; notifies PI &
Protocol Office.
Protocol Office posts protocol
and related documents on
Clinical FYI.
Category IV"Minimal Risk"
Protocols
PreliminaryPIM
Wednesdays
Distribution Memo
Safe Medical Practice Review
Protocol Revision
Confidential
Oncology Protocol Pathway
Protocol is submitted to
Protocol Office.2 weeks
Scientific Review Committee
Meeting(SRC)
Clinical Trial Implementation
(CTI)2-3 weeks
2+ w
eeks
Institutional Review Boards
(IRB)0-30 days
Protocol Office posts protocol
and related documents on
Clinical FYI.
Category IV"Minimal Risk"
Protocols
2-3 weeks
Radiation Safety Committee
(RSC) if applicable
2-3 weeks
Institutional Biosafety
Committee (IBC) if applicable
Confidential
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
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
Depts./Services Represented at Research Implementation Meetings
Research Implementation
Meeting(CTI/PIM)
Clinical Laboratories (8)
Imaging Services
Infusion Services
Gen Onc/Hem Clinics
Women's Center
HCT Transplant Clinic
IP Nursing
Apheresis
Procedure Suite
Material Management
Research Billing Office
Pharmacy/IDS
Cellular Therapeutics
(CTL)
Clinical Trial Representative
Confidential
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: [email protected]