clinical research studies janette hannam, ms, ctra asst. director for research, osp
TRANSCRIPT
![Page 1: CLINICAL RESEARCH STUDIES Janette Hannam, MS, CTRA Asst. Director for Research, OSP](https://reader036.vdocuments.net/reader036/viewer/2022083007/56649e995503460f94b9bbae/html5/thumbnails/1.jpg)
CLINICAL RESEARCH STUDIES
Janette Hannam, MS, CTRA
Asst. Director for Research, OSP
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WHY DO CLINICAL TRIALS?
• New patient treatments
• Further University research efforts
• Partnership with industry
• Increase research funding
• Opportunity for investigators to publish
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Sources of Sponsored Research$353,908,822
Foreign$1,211,912
State$2,705,230
University$22,397,225
Federal$256,701,835
Corporate$16,102,273
Private$54,790,347
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How do I get started?
• Route COMPLETE proposal to:• Human Investigations Committee
(HIC)• Office of Sponsored
Programs(OSP)
• DO NOT need HIC approval prior to routing to OSP!!
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WHAT DO I ROUTE?
• COMPLETE PROPOSAL consists of:– Sponsored Programs Approval Form(SPAF)– Protocol including informed consent and/
subject authorization– Budget– Clinical Trial Agreement– Name and phone numbers for company
contacts
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WHEN DO I ROUTE?
•YESTERDAY!!• When ALL documents are received
– The worse thing you can do is route an incomplete package
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WHY DO I ROUTE?
• To insure that ALL University authorities are in agreement with protocol/research that is being proposed.
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SPAFSponsored Programs Approval Form
• Why do I need a SPAF??– Indicates approval from:
• Supervisor
• Division Chief, if necessary
• Chair
• Dean, School of Medicine
• Office of Sponsored Programs
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PROTOCOL
• Purpose– Allows those approving protocol/research to
review what work is to be performed– Outlines specifically what will be done– Instructs all those working on project– Gives clinical contacts at company– Becomes document of record should litigation
occur
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BUDGET• Indicates how research funding is to be allocated• Gives Department and School benchmarks for
internal budget projections• Provides Office of Grants and Contracts
guidelines on receipts and expenses
• Supports legal contract • Shows indirect cost rate
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Clinical Trial Agreement
• Creates legal document between Company and University
• Gives clear definitions as to what Company and University have agreed to
• Must be executed by University official(OSP)
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Key Elements in CTA
• Recitals(who, what, when & where)
• Dates
• Dollars
• Indemnification
• Termination
• Confidentiality
• Publication
• Data Ownership
• License & Patents
• Legal Jurisdiction
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What is OSP’s involvement?• Negotiate language in clinical trial
agreement with company
• Execute documents on behalf of University
• Insure HIC compliance
• Act as liaison between University, Company, other University offices
• Coordinate documents
• Complete award process(account number)
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When can we see patients?
• All documents are signed
• OSP receives fully executed original clinical trial agreement
• HIC approval is obtained
• NOA is completed and sent to OGCA
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When do I get an account number?
• All documents are signed
• OSP receives fully executed original clinical trial agreement
• HIC is approved
• Office of Grants and Contracts has given account number to OSP
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When can I use the new account number?
• After OSP does Notice of Acceptance
• After OGCA inputs NOA information
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Why can’t the investigator sign clinical trial agreement?
• Not authorized by University to enter into contracts on behalf of University
• Insures compliance to policy and procedures
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QUESTIONS