Strategic Development and Expansion of the Clinical Trials Infrastructure

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


PI revisions

CC-IRB Chair review and

decision



review

Approved


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





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


Questions

Dept Admin:Fred Appelbaum

reviews eGC1 packet


Approve

Questions

DOM:Harriet reviews

eGC1 packet


Approve

Questions

SOM:Janelle reviews eGC1 packet


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


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


No

Submit revised eGC1 w/budget

PI approvalDepartment

administrationreview


Questions

Approves DOM review


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


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)


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)


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


and sends materials to subset of RSC for expedited review


Questions/changes

requested

Does it meet the definition of minimal

risk?

No

Using healthy volunteers or

minors?Yes

Yes


No

Does SCCA RSO have questions

for research team?


Yes


expedited review?

No

Full SCCA RSC Review


Expedited review by SE and RSO


Yes

No

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


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?


Yes

UW IBC review (meets quarterly)



Prepare UW IBC approval documentApprove

Submit materials to CTI 2 weeks

prior to IBC meeting




Yes

Full SCCA IBC review

(meets monthly)


Major questions/revisions requested


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


WIRB




WIRB




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


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

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


Approved

PI revisionsIndividual SRC

reviewer decision


SRC approval documents generated

Request changes or additional information/documents

Scientific ReviewPI and/or their Research Team



Western IRB







Legend

Colors

Shapes






WIRB or CCIRB?

Submit documents to FH Institutional

Review Office (IRO)

CC-IRB


review


IRB AnalystPI revisions

Full CC-IRB review and

decision

PI revisions


PI revisions


decision



review

Approved


IRB Analyst

CC-IRB Contingent Approval Letter

Initial CC-IRB Review

Was IRB application included in PO submission?

Yes

Complete IRB application

No




Western IRB







Legend

Colors

Shapes






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




Western IRB







Legend

Colors

Shapes






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









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



Western IRB







Legend

Colors

Shapes






Assigned to Budgeting Specialist. Reviewed for:· Billing grid completeness· Consistency between protocol,

consent, & contract· Fiscal reasonableness

Questions for the research staff/PI?


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


response




Western IRB







Legend

Colors

Shapes






CC-IRB receives closure memo

summarizing SFI and management plan

Office of Research conducts review

Did CC-IRB already review SFI in


CC-IRB

WIRB receives closure memo summarizing

SFI and management plan

Did WIRB already review SFI in


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




Western IRB







Legend

Colors

Shapes











Yes

No


signed by PI

SCCA Only






Yes


and sends materials to Radiation Safety

Committee (RSC)

No




Questions/changes

requested?



Approved




expedited review?

No



meeting)

Yes




Questions/changes

requested


risk?

No


minors?Yes

Yes


No


for research team?


Yes


expedited review?

No





Yes

No





No

Consultant review

Yes


send to PIApproved

Approved


SCCA?Yes








WIRB




Western IRB







Legend

Colors

Shapes











Yes

No


signed by PI

SCCA Only






Yes


and sends materials to Radiation Safety Committee (RSC)

No




Questions/changes

requested?



Approved




expedited review?

No



meeting)

Yes




Questions/changes

requested


risk?

No


minors?Yes

Yes


No


for research team?


Yes


expedited review?

No





Yes

No





No

Consultant review

Yes


send to PI

Approved

Approved


SCCA?Yes








WIRB




Western IRB







Legend

Colors

Shapes






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


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

Wait for budget

No




Western IRB







Legend

Colors

Shapes






Submit revised eGC1 w/budget

PI approvalDepartment

administrationreview


Questions

Approves DOM review


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




Western IRB







Legend

Colors

Shapes






Final CC-IRB Approval Letter


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




Western IRB







Legend

Colors

Shapes






Does the study include

biohazards or recombinant

DNA?


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




Yes

UW IBC review (meets quarterly)



Prepare UW IBC approval documentApprove

Submit materials to CTI 2 weeks

prior to IBC meeting




Yes

Full SCCA IBC review

(meets monthly)


Major questions/revisions requested


Minor questions/revisions requested

SCCA IBC Chair review

Questions/changes requested

Prepare SCCA IBC approval documentApprove

Approve

SCCA

UW

Institutional Biosafety Committee Review




WIRB




WIRB




Western IRB







Legend

Colors

Shapes






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

[email protected]

Strategic Development and Expansion of the Clinical Trials Infrastructure

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Transcript of Strategic Development and Expansion of the Clinical Trials Infrastructure