strategic development and expansion of the clinical trials infrastructure
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The goal is to improve the quality of the clinical trials and increase the number of clinical trials.TRANSCRIPT
Strategic Development and Expansion of the Clinical Trials
Infrastructure
Lynne ChronisterAssistant Vice Provost
University of Washington
Are we
Missing
something
Here?
GOALS
1. Improve the Quality of the Clinical Trials.
AND/OR
2. Increase the Number of Clinical Trials.
Session Objectives
1. Identify Non-clinical Components Needed for Building and Sustaining a Successful Clinical Trials Program
1. Look at Tools That can be used to Reach identified Goals and Outcomes
Examples
• University of California, Davis
• University of Washington
1. What Do we Need to be Successful
• Leadership
• Infrastructure
• Appropriate Staffing
• Effective and Efficient Processes
• Policies and Practices
Leadership
One of the most critical components to enhancing or improving the clinical trials program is the commitment and engagement of senior leadership.
Infrastructure
Budgeting OfficeSponsored ProgramsAnatomical Specimens/Human TissueEnvironmental Health/SafetyCompliance/IRB/Conflict of Interest/HIPAAAccount PayablesGeneral CounselRisk Management/InsuranceClinical Trials Office/Clinical Study CoordinatorsIndustry RelationsMedical Records(electronic record of participation)
Appropriate Staffing
Clinical Trials Office?BudgetingNegotiationsFacilitationCompliance
BillingRegulatory
Processes
Internal approval of clinical trialsBudgeting of Clinical trial costsInvoicing for clinical trialsEnsuring no invoicing for standard of CareGood Clinical PracticesTraining:
InvestigatorsCoordinators
Policies and Practices
Policy on Gifts Policy on indirect costPolicy on Conflict of InterestPolicy on who can be a “PI”Policy on who can consentPolicy on TrainingPolicy on Data Safety and MonitoringPolicy on use of Residual Funds
Standard Definitions
• What is a clinical trial?
“Clinical trials are voluntary research studies, conducted in people, that are designed to answer specific questions about the safety and/or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments”
FDA
2. Tools we can Use to Get There
• Process Chart
• Gap Analysis
• Roadmap
Flow Diagrams
The first step in any process is to figure out the current process and map it out thoroughly.
UW or both UW and SCCA
Protocol Ready for Submission ProcessSteps that will have already occurred:· CDA· Site visit· Agreement to perform protocol
Prepare and submit the following documents to the Protocol Office (PO)· PO submission checklist· UW coversheet· IRB application form (optional)· Protocol· Consents· Synopsis (if applicable)· Assent (if applicable)· Investigator’s Brochure (if applicable)
WIRB or CCIRB?Initial document
review
Assigns WIRB protocol number
Assigns CC-IRB protocol number
WIRB
CC-IRB
Process documents for
Scientific Review Committee (SRC)
Full SRC review and decision
PI revisions
Not Approved orMajor Revision Requested
Approved
PI revisionsIndividual SRC
reviewer decision
Minor Revision Requested
SRC approval documents generated WIRB or CCIRB?
Prepare documents for WIRB submission
WIRB
Submit documents to FH Institutional
Review Office (IRO)
CC-IRB
IRB Analyst review and processing of documents for IRB
review
Changes requested from
IRB AnalystPI revisions
Full CC-IRB review and
decision
Request changes or additional information/documents
PI revisions
Not Approved orMajor Revision Requested
PI revisions
CC-IRB Chair review and
decision
Minor Revision Requested
IRB Analyst review and processing of documents for IRB
review
Approved
Changes requested from
IRB Analyst
Processes documents· Makes packets· Evaluates information· Schedules review
Full WIRB review and
decision
PI revisions
Changes requested
Approved
Determine which procedures are
research vs. standard of care
Who performs procedures? UW, SCCA or both?
Prepare and submit pricing pages to Clinical Trials Implementation
Committee (CTI)
Prepare and submit AAA pricing pages to
individual UW departments
Review and distribute to appropriate departments
Department A provides pricing information
Department B provides pricing information
Department C provides pricing information
Department D provides pricing information
Department A provides pricing information
Department B provides pricing information
Department C provides pricing information
Department D provides pricing information
SCCA
UW
Prices pages returned, filed, and
CTI committee meeting scheduled
CTI Committee meeting
Prepare and submit additional pricing pages
to CTIAdditional Pricing
Needed
Compiles pricing information
ApprovedAssigned to Budgeting Specialist. Reviewed for:· Billing grid completeness· Consistency between protocol,
consent, & contract· Fiscal reasonableness
Questions for the research staff/PI?
Contact research staff. Placed in pending waiting
response
Answer questions
Yes
Who will perform budget negotiation?
No
Budget negotiation
Research staff
Budget negotiation
CRBB
Budget insufficiency?
Dept. chair and administrator
approval?Yes
Any changes to budget by research
staff?
No
Make changes to budget
Yes Study is terminatedNo
Send research staff final CRBB budget
Prepare and route eGC1 packet (w/o budget):· Proposed contract· Protocol· SFI form and letter/proposal· SOM code classification· Site inventory
PI approval
Answers questions and makes revisions
Questions
Dept Admin:Susan or Sandra
reviews eGC1 packet
Approve
Answers questions and makes revisions
Questions
Dept Admin:Fred Appelbaum
reviews eGC1 packet
Answers questions and makes revisions
Approve
Questions
DOM:Harriet reviews
eGC1 packet
Answers questions and makes revisions
Approve
Questions
SOM:Janelle reviews eGC1 packet
Answers questions and makes revisions
Approve
Questions
Office of Sponsored Programs (OSP) receives eGC1
Assigned to appropriate administrator
Reviews documents and prepares for negotiation
Contract negotiationAgreement on
contract?Yes
Contract negotiation
Budget negotiation
Budget negotiation
UW Study Start-up Process Flow ChartUpdated: December 19, 2007
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
CC-IRB Contingent Approval Letter
WIRB Approval Letter
Other Department Reviews
Answers questions and makes revisions
Questions
Approve
Yes
SOM:Is SFI involved?
No
CC-IRB receives closure memo
summarizing SFI and management plan
Office of Research conducts review
Initial CC-IRB Review No
Did CC-IRB already review SFI in
context of IRB application and consent?
Yes
Final CC-IRB Approval Letter
CC-IRB
WIRB receives closure memo summarizing
SFI and management plan
Did WIRB already review SFI in
context of IRB application and consent?
No
Submit revised eGC1 w/budget
PI approvalDepartment
administrationreview
Answers questions and makes revisions
Questions
Approves DOM review
Answers questions and makes revisions
Questions
DOM re-submits eGC-1
Notifies OSP of contract execution and reminds
them of advance budget number request
OSP gathers advance budget request/contract
paperwork
Does IRB approved consent match
contract?
Yes
CC-IRB or WIRB?
Submit modification to CC-IRB with final contract
CC-IRB
CC-IRB Chair review and
decision
IRB Analyst review and processing of documents for IRB review. Checks for:· Final contract· IBC· RSC
Yes
Revisions No
OSP Approval?(John Streck)
Hard copy of NEA delivered to GCA
(deliveries once per day)Yes
Drafts NEA GCA issues budget number and emails it to
research teamEmails CTI CTI emails CRBB
CRBB issues AAA number
Ready to Enroll!!!
Human Subjects Office Reviews
No
No further action required
Is radiation performed during
study? (even if it is SOC)
No further action required
Where will radiation be performed?
Yes
No
Prepare UW radiation safety application
signed by PI
SCCA Only
DOM signs and sends back to research team
Send hard copies of the following documents to Radiation Safety Officer (RSO):· Radiation safety application· Protocol· Consent· IRB application
RSO ReviewDoes RSO have
questions for research team?
Address questions and make changes
Yes
RSO generates summary document
and sends materials to Radiation Safety
Committee (RSC)
No
RSC review and decisions
(meets 2nd Wed of odd months)
Address questions and make changes
Questions/changes
requested?
Prepare RSC approval document. Copy sent
to CC-IRB and research team.
Approved
Submit UW Form 30 or 31 and UW approval to
SCCA RSOSCCA RSO reviews
Does the study include
biohazards or recombinant
DNA?
Does study qualify for
expedited review?
No
Expedited RSC review
(does not have to wait for full committee
meeting)
Yes
RSO generates summary document
and sends materials to subset of RSC for expedited review
Address questions and make changes
Questions/changes
requested
Does it meet the definition of minimal
risk?
No
Using healthy volunteers or
minors?Yes
Yes
No further action required
No
Does SCCA RSO have questions
for research team?
Address questions and make changes
Yes
Does study qualify for
expedited review?
No
Full SCCA RSC Review
Address questions and make changes
Expedited review by SE and RSO
Address questions and make changes
Yes
No
Questions/Changes Requested
Questions/Changes Requested
Is study unusual, involve minors or
healthy participants or a high dose?
No
Consultant review
Yes
Generate SCCA RSC approval document and
send to PI
Approved
Approved
Is any radiation performed at the
SCCA?Yes
No further action required
Where will study be performed?
Yes
No
Contact UW RBSO to ask when next meeting will
be held
Submit Form SCCA 30 to SCCA RSO
Submit Form SCCA 30 with
explanation to SCCA RSO
Complete and submit the following to RSBO at least 4 weeks prior to IBC meeting:
· Research Project Hazard Assessment form
· Current GC-1 abstract or project description
· Protocol
RBSO reviews materials
Does RBSO have questions?
Address questions and make changes
Yes
UW IBC review (meets quarterly)
Address questions and make changes
Questions/Changes Requested
Prepare UW IBC approval documentApprove
Submit materials to CTI 2 weeks
prior to IBC meeting
RBSO reviews materials
Does RBSO have questions?
Address questions and make changes
Yes
Full SCCA IBC review
(meets monthly)
Address questions and make changes
Major questions/revisions requested
Address questions and make changes
Minor questions/revisions requested
SCCA IBC Chair review
Questions/changes requested
Prepare SCCA IBC approval documentApprove
Approve
SCCA
UW
Scientific Review
WIRB Review
Final CC-IRB Review
Obtaining Pricing Information CRBB: Budget Development and Negotiation
Initial eGC1 Review
Significant Financial Interest Review
OSP: Contract Negotitation
Final GC-1 and Advance Budget Number
Radiation Safety Review
Institutional Biosafety Committee Review
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Was IRB application included in PO submission?
Yes
Complete IRB application
No
IC/Contract Funding Source
Document Review by FHCRC GC
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
Who will complete detailed
budget tool?
Research staff submits:· Detailed budget tool· Pricing pages· Protocol· ICF· Contract· Sponsor proposed budget
Research staff submits:· Budget checklist· Pricing pages· Protocol· ICF· Contract· Sponsor proposed budget
Research Staff
CRBB
CRBB performs triage to check for complete
documents
All required study
documents received?
Provide additional information/documents
Yes
No
Research staff/PI sign-off on study
budget
Answer questions
Budget have excessive residuals?
Yes
Submit to Director of Regulatory Affairs,
SOM, Dean’s Office for notification
Review email to PI, research staff,
administrator, SOM, Dean’s office and OSP summarizing budget
No
No/Yes
Yes
Does study involve SFI?
OSP transmits SFI package to Office of
Research
Yes
No Is a CRO involved?
Letter of indemnification requested
Yes
No
Study is terminated
No
Involve Associate Director.
Agreement?
Involve Director.
Agreement?
No
WIRB
Has SFI been cleared?
Wait for clearance
No
Who signs first?Yes
PI Signs Contract
UW
OSP Signs Contract
Sponsor signs contractSponsor
Sponsor signs contract
PI Signs Contract OSP Signs Contract
OSP sends copy of final contract to research staff
Research team receives signed contract
Research staff/PI negotiates needed
changes with company
Negotiates ICF changes
PI completes SFI form and letter
OR sends SFI package to Vice Dean
of Medicine
Vice Dean of Medicine reviews, writes report/
recommendation to OR
OR makes final decision. Writes resolution letter with
copies to PI, CC-IRB or WIRB, department chair, dean, OSP
and sponsorCC-IRB or WIRB?
WIRB
No
Yes
Yes
Research team sends email notification to OSP
Withdraw GC-1
Contact research staff. Placed in pending waiting
response
Has budget been negotiated?
Yes
Is an advance budget number being requested
Complete advanced budget number request DOM sends email
notification to OSP
Was an advanced budget number
requested?
No further action required
No
Yes
Research team re-submits eGC-1
Wait for budget
No
Prepare and submit the following documents to the Protocol Office (PO)· PO submission checklist· UW coversheet· IRB application form (optional)· Protocol· Consents· Synopsis (if applicable)· Assent (if applicable)· Investigator’s Brochure (if applicable)
WIRB or CCIRB?Initial document
review
Assigns WIRB protocol number
Assigns CC-IRB protocol number
WIRB
CC-IRB
Process documents for
Scientific Review Committee (SRC)
Full SRC review and decision
PI revisions
Not Approved orMajor Revision Requested
Approved
PI revisionsIndividual SRC
reviewer decision
Minor Revision Requested
SRC approval documents generated
Request changes or additional information/documents
Scientific ReviewPI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
WIRB or CCIRB?
Submit documents to FH Institutional
Review Office (IRO)
CC-IRB
IRB Analyst review and processing of documents for IRB
review
Changes requested from
IRB AnalystPI revisions
Full CC-IRB review and
decision
PI revisions
Not Approved orMajor Revision Requested
PI revisions
CC-IRB Chair review and
decision
Minor Revision Requested
IRB Analyst review and processing of documents for IRB
review
Approved
Changes requested from
IRB Analyst
CC-IRB Contingent Approval Letter
Initial CC-IRB Review
Was IRB application included in PO submission?
Yes
Complete IRB application
No
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Prepare documents for WIRB submission
Processes documents· Makes packets· Evaluates information· Schedules review
Full WIRB review and
decision
PI revisions
Changes requested
ApprovedWIRB Approval Letter
WIRB Review
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Determine which procedures are
research vs. standard of care
Who performs procedures? UW, SCCA or both?
Prepare and submit pricing pages to Clinical Trials Implementation
Committee (CTI)
Prepare and submit AAA pricing pages to
individual UW departments
Review and distribute to appropriate departments
Department A provides pricing information
Department B provides pricing information
Department C provides pricing information
Department D provides pricing information
Department A provides pricing information
Department B provides pricing information
Department C provides pricing information
Department D provides pricing information
SCCA
UW
Prices pages returned, filed, and
CTI committee meeting scheduled
CTI Committee meeting
Prepare and submit additional pricing pages
to CTIAdditional Pricing
Needed
Compiles pricing information
Obtaining Pricing InformationPI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Assigned to Budgeting Specialist. Reviewed for:· Billing grid completeness· Consistency between protocol,
consent, & contract· Fiscal reasonableness
Questions for the research staff/PI?
Contact research staff. Placed in pending waiting
response
Answer questions
Yes
Who will perform budget negotiation?
No
Budget negotiation
Research staff
Budget negotiation
CRBB
Budget insufficiency?
Dept. chair and administrator
approval?Yes
Any changes to budget by research
staff?
No
Make changes to budget
Yes Study is terminatedNo
Send research staff final CRBB budget
Budget negotiation
Budget negotiation
CRBB: Budget Development and Negotiation
Who will complete detailed
budget tool?
Research staff submits:· Detailed budget tool· Pricing pages· Protocol· ICF· Contract· Sponsor proposed budget
Research staff submits:· Budget checklist· Pricing pages· Protocol· ICF· Contract· Sponsor proposed budget
Research Staff
CRBB
CRBB performs triage to check for complete
documents
All required study
documents received?
Provide additional information/documents
Yes
No
Research staff/PI sign-off on study
budget
Answer questions
Budget have excessive residuals?
Yes
Submit to Director of Regulatory Affairs,
SOM, Dean’s Office for notification
Review email to PI, research staff,
administrator, SOM, Dean’s office and OSP
summarizing budget
No
No/Yes
Yes
Contact research staff. Placed in pending waiting
response
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
CC-IRB receives closure memo
summarizing SFI and management plan
Office of Research conducts review
Did CC-IRB already review SFI in
context of IRB application and consent?
CC-IRB
WIRB receives closure memo summarizing
SFI and management plan
Did WIRB already review SFI in
context of IRB application and consent?
Significant Financial Interest Review
OSP transmits SFI package to Office of
Research
PI completes SFI form and letter
OR sends SFI package to Vice Dean
of Medicine
Vice Dean of Medicine reviews, writes report/
recommendation to OR
OR makes final decision. Writes resolution letter with
copies to PI, CC-IRB or WIRB, department chair, dean, OSP
and sponsorCC-IRB or WIRB?
WIRB
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
UW or both UW and SCCA
Is radiation performed during
study? (even if it is SOC)
No further action required
Where will radiation be performed?
Yes
No
Prepare UW radiation safety application
signed by PI
SCCA Only
DOM signs and sends back to research team
Send hard copies of the following documents to Radiation Safety Officer (RSO):· Radiation safety application· Protocol· Consent· IRB application
RSO ReviewDoes RSO have
questions for research team?
Address questions and make changes
Yes
RSO generates summary document
and sends materials to Radiation Safety
Committee (RSC)
No
RSC review and decisions
(meets 2nd Wed of odd months)
Address questions and make changes
Questions/changes
requested?
Prepare RSC approval document. Copy sent
to CC-IRB and research team.
Approved
Submit UW Form 30 or 31 and UW approval to
SCCA RSOSCCA RSO reviews
Does study qualify for
expedited review?
No
Expedited RSC review
(does not have to wait for full committee
meeting)
Yes
RSO generates summary document
and sends materials to subset of RSC for expedited review
Address questions and make changes
Questions/changes
requested
Does it meet the definition of minimal
risk?
No
Using healthy volunteers or
minors?Yes
Yes
No further action required
No
Does SCCA RSO have questions
for research team?
Address questions and make changes
Yes
Does study qualify for
expedited review?
No
Full SCCA RSC Review
Address questions and make changes
Expedited review by SE and RSO
Address questions and make changes
Yes
No
Questions/Changes Requested
Questions/Changes Requested
Is study unusual, involve minors or
healthy participants or a high dose?
No
Consultant review
Yes
Generate SCCA RSC approval document and
send to PIApproved
Approved
Is any radiation performed at the
SCCA?Yes
Submit Form SCCA 30 to SCCA RSO
Submit Form SCCA 30 with
explanation to SCCA RSO
Radiation Safety Review
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
UW or both UW and SCCA
Is radiation performed during
study? (even if it is SOC)
No further action required
Where will radiation be performed?
Yes
No
Prepare UW radiation safety application
signed by PI
SCCA Only
DOM signs and sends back to research team
Send hard copies of the following documents to Radiation Safety Officer (RSO):· Radiation safety application· Protocol· Consent· IRB application
RSO ReviewDoes RSO have
questions for research team?
Address questions and make changes
Yes
RSO generates summary document
and sends materials to Radiation Safety Committee (RSC)
No
RSC review and decisions
(meets 2nd Wed of odd months)
Address questions and make changes
Questions/changes
requested?
Prepare RSC approval document. Copy sent
to CC-IRB and research team.
Approved
Submit UW Form 30 or 31 and UW approval to
SCCA RSOSCCA RSO reviews
Does study qualify for
expedited review?
No
Expedited RSC review
(does not have to wait for full committee
meeting)
Yes
RSO generates summary document
and sends materials to subset of RSC for expedited review
Address questions and make changes
Questions/changes
requested
Does it meet the definition of minimal
risk?
No
Using healthy volunteers or
minors?Yes
Yes
No further action required
No
Does SCCA RSO have questions
for research team?
Address questions and make changes
Yes
Does study qualify for
expedited review?
No
Full SCCA RSC Review
Address questions and make changes
Expedited review by SE and RSO
Address questions and make changes
Yes
No
Questions/Changes Requested
Questions/Changes Requested
Is study unusual, involve minors or
healthy participants or a high dose?
No
Consultant review
Yes
Generate SCCA RSC approval document and
send to PI
Approved
Approved
Is any radiation performed at the
SCCA?Yes
Submit Form SCCA 30 to SCCA RSO
Submit Form SCCA 30 with
explanation to SCCA RSO
Radiation Safety Review
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Office of Sponsored Programs (OSP) receives eGC1
Assigned to appropriate administrator
Reviews documents and prepares for negotiation
Contract negotiationAgreement on
contract?Yes
Contract negotiation
Notifies OSP of contract execution and reminds
them of advance budget number request
Does IRB approved consent match
contract?
Yes
CC-IRB or WIRB?
Submit modification to CC-IRB with final contract
CC-IRB
Human Subjects Office Reviews
No
No further action required
OSP: Contract Negotitation
Does study involve SFI?
No Is a CRO involved?
Letter of indemnification requested
Yes
No
Study is terminated
No
Involve Associate Director.
Agreement?
Involve Director.
Agreement?
No
WIRB
Has SFI been cleared?
Wait for clearance
No
Who signs first?Yes
PI Signs Contract
UW
OSP Signs Contract
Sponsor signs contractSponsor
Sponsor signs contract
PI Signs Contract OSP Signs Contract
OSP sends copy of final contract to research staff
Research team receives signed contract
Research staff/PI negotiates needed
changes with company
Negotiates ICF changes
No
Yes
Yes
Has budget been negotiated?
Yes
Was an advanced budget number
requested?
No further action required
No
Wait for budget
No
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Submit revised eGC1 w/budget
PI approvalDepartment
administrationreview
Answers questions and makes revisions
Questions
Approves DOM review
Answers questions and makes revisions
Questions
DOM re-submits eGC-1
OSP gathers advance budget request/contract
paperwork
OSP Approval?(John Streck)
Hard copy of NEA delivered to GCA
(deliveries once per day)Yes
Drafts NEA GCA issues budget number and emails it to
research teamEmails CTI CTI emails CRBB
CRBB issues AAA number
Final GC-1 and Advance Budget Number
Research team sends email notification to OSP
Withdraw GC-1Is an advance budget number being requested
Complete advanced budget number request DOM sends email
notification to OSP
Research team re-submits eGC-1
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Final CC-IRB Approval Letter
CC-IRB Chair review and
decision
IRB Analyst review and processing of documents for IRB review. Checks for:· Final contract· IBC· RSC
Yes
Revisions No
Final CC-IRB Review
IC/Contract Funding Source
Document Review by FHCRC GC
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
Does the study include
biohazards or recombinant
DNA?
No further action required
Where will study be performed?
Yes
No
Contact UW RBSO to ask when next meeting will
be held
Complete and submit the following to RSBO at least 4 weeks prior to IBC meeting:
· Research Project Hazard Assessment form
· Current GC-1 abstract or project description
· Protocol
RBSO reviews materials
Does RBSO have questions?
Address questions and make changes
Yes
UW IBC review (meets quarterly)
Address questions and make changes
Questions/Changes Requested
Prepare UW IBC approval documentApprove
Submit materials to CTI 2 weeks
prior to IBC meeting
RBSO reviews materials
Does RBSO have questions?
Address questions and make changes
Yes
Full SCCA IBC review
(meets monthly)
Address questions and make changes
Major questions/revisions requested
Address questions and make changes
Minor questions/revisions requested
SCCA IBC Chair review
Questions/changes requested
Prepare SCCA IBC approval documentApprove
Approve
SCCA
UW
Institutional Biosafety Committee Review
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
WIRB or CCIRB?Send SCCA RSC
approval to CC-IRBCC-IRB
No further action required
WIRB
PI and/or their Research Team
FHCRC Protocol Office
FHCRC Institutional Review Office/CC-IRB
Western IRB
SCCA Clinical Trials Implementation Office
Clinical Research Budgeting and Billing (CCRB)
Pharmaceutical Company/Industry Sponsor
Office of Sponsored Programs (OSP)
Miscellaneous UW Departments
Not Applicable or Involves Multiple Groups
Legend
Colors
Shapes
Process Decision Document
Starting or Ending Point
UW Radiation Safety Committee (RSC)
SCCA Radiation Safety Committee
UW Research & Biological Safety Office (RBSO)
ExampleGRANT MANAGEMENT
Billing human subjects/payors
Applicable Regulations, Policies, Guidelines and Accrediting Bodies/Requirements
Is a Policy Needed or Required?
What is the Applicable Current UC Policy? If it exists, does it need to be revised/updated?
Who is Accountable for Operational Compliance?
Who is Responsible for Monitoring and Auditing
Who is Accountable for Campus Enforcement and Discipline?
Is there an Oversight Committee (Chair)? If so, who?
Is Training Required by External Regulations?
Is Training Currently Available and Adequate
Is Training Required by Internal Policy
Target Audience for Training
Program Models (website)
Other Relevant Information
Gap Analysis
An assessment tool to identify the gap between actual performance to preferred performance achievements
Or
An assessment tool comparing a groups’ current activities with what they should be doing.
Gaps
Clinical Trial Model Clinical Trial Actual
30 days to complete 200 days to complete
Concurrent IRB review Consecutive Review
40 days IRB turnaround 120 days turnaround
Gap Analysis
• Use visioning to identify where the group wants to be at a specific time and post on one side of the wall
• Identify the present state and post the details on the opposite wall
• Instruct the group to work with partners to identify the gaps • Share the ideas/gaps as a group and post on the wall
between the other two lists • Reach consensus on the gaps and reassemble the whole
group to hear recommendations and action plans • Create a means for follow-up
(L+M) Consulting
Stanford Responsibility Chart COGNIZANT
POLICY OFFICE OFFICER
FUNCTIONALLY RESPONSIBLE OFFICE
OFFICER
PRIMARY LOCUS OF RESPONSIBILITY
EH&S Dean of Research & Graduate Policy
EH&S PI’s
Medicare Billing VP for Medical Affairs SHC Compliance Office Medical Faculty SHC Compliance Office
Research/ Administration
Dean of Research & Graduate Policy, Assoc. VP for Research Admin.
Office of the Dean of Research
Office of Research Admin
PI’s/Departments
Scientific Misconduct
Dean of Research & Graduate Policy
Office of the Dean of Research
Schools
Human/Animal Subjects
Dean of Research & Graduate Policy
Administrative Panels, Compliance Office
PI’s
HR/EEOC VP for Business Affiars Human Resources Departments, Central HR
NCAA Provost DAPER Coaches
Fire and Bldg Safety VP for Land & Buildings EH&S/Fire Marshal EH&S/Schools/ Departments
IRS & CA Tax VP for Business Affiars Controller FAIR Group
Donor Gift Restrictions
President Office of Development SMC Schools/Departments/
Faculty Conflicts of Interest Provost Dean of Research &
Graduate Policy Business Affairs
Schools/Faculty, Controller,
Director of Procurement Immigration VP for Business Affairs Human Resources Departments,
Central HR Technology Licens’g/ Intellectual Property
Dean of Research & Graudate Policy
Office of Technology Licensing
OTL, Faculty
Land Use VP for Land & Buildings SMC/CP&M SMC/CP&M
Roadmap
In order to get where you need to know –it is much easier if you know where you are going and the route you are taking!
Roadmapping
Activity Finish Date Responsible Party Done
Contact Information
Lynne Chronister
Assistant Vice Provost and
Director of Sponsored Programs
206-543-4043