Research Orientation to SCCA
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
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Relationship of SCCA, FHCRC, UW and SCH
Oncology Care Delivery System
UWMC Adult IP
Inpatient
Facilities
Outpatient
Facilities
SCCA
Adult IP
(20 beds)
UWMC
OP Oncology Services
8NE
SC Pediatric IP
(38 beds)
(Adult)
Infusion
Clinic
Radiation
Diagnostic
Procedures
(Major/Minor)
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Seattle Children’s
OP Oncology Services
SCCA
OP Oncology Services
(Pediatric)
Infusion
Clinic
Radiation
Diagnostic
Procedures
(Minor)
Infusion
Clinic
Diagnostic
Procedures
(Major/Minor)
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.
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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.
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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).
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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.
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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.
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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.
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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.
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The Path of a Clinical Trial
• Principal Investigator (PI)
or sponsor has an idea;
• Investigator/sponsor
works with coinvestigators,
administration, sponsor
and Research Consortium
to develop the protocol
and consent documents.
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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]).
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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.
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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
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Path of a Clinical Trial
• Protocol submitted to
SCCA Research
Implementation Office
(RIO) for review of
implementation
issues.
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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
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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;
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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.
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BMT Protocol Pathway
Preliminary
Safe
Medical
Practice
Review
Protocol
Revision
PIM
Wednesdays
Protocol is
submitted to
Research
Trials Office.
2 weeks
CRD
Clinical
Investigators
Meeting
1 week
Scientific
Review Committee
Meeting
(CIM)
(SRC)
(PIM)
2nd & 4th
Monday
Wednesdays
s
Tuesdays
2-3 weeks
Protocol
Implementation
Meeting
3 weeks
2+
we
ek
Protocol Implementation
Category IV
"Minimal Risk"
Protocols
PI submits protocol
and related documents
to IRB for review.
Institutional
Review Boards
(IRB)
2nd & 4th
Wednesday
Protocol Design
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0-30 days
IRB reviews
and approves
protocol;
notifies PI &
Protocol Office.
Protocol Office
posts protocol
and related
documents on
Clinical FYI.
Distribution
Memo
Oncology Protocol Pathway
Protocol is
submitted to
Protocol Office.
2 weeks
Scientific
Review Committee
Meeting
(SRC)
2-3 weeks
Clinical Trial
Implementation
2-3 weeks
(CTI)
Radiation Safety
Committee
(RSC)
if applicable
3
2ee
w
ks
2+ weeks
Institutional
Biosafety
Committee (IBC)
if applicable
Category IV
"Minimal Risk"
Protocols
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Institutional
Review Boards
(IRB)
0-30 days
Protocol Office
posts protocol
and related
documents on
Clinical FYI.
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
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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?
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Depts./Services Represented at Research Implementation Meetings
Clinical Trial
Representative
Cellular
Therapeutics
(CTL)
Clinical
Laboratories (8)
Imaging
Services
Infusion
Services
Pharmacy/IDS
Gen Onc/Hem
Clinics
Women's Center
Material
Management
Apheresis
HCT
Transplant Clinic
Procedure Suite
IP Nursing
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Research Billing
Office
Research
Implementation
Meeting
(CTI/PIM)
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
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