CLINICAL RESEARCH STUDIES

Janette Hannam, MS, CTRA

Asst. Director for Research, OSP

WHY DO CLINICAL TRIALS?

• New patient treatments

• Further University research efforts

• Partnership with industry

• Increase research funding

• Opportunity for investigators to publish

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

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!!

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

WHEN DO I ROUTE?

•YESTERDAY!!• When ALL documents are received

– The worse thing you can do is route an incomplete package

WHY DO I ROUTE?

• To insure that ALL University authorities are in agreement with protocol/research that is being proposed.

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

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

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

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)

Key Elements in CTA

• Recitals(who, what, when & where)

• Dates

• Dollars

• Indemnification

• Termination

• Confidentiality

• Publication

• Data Ownership

• License & Patents

• Legal Jurisdiction

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)

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

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

When can I use the new account number?

• After OSP does Notice of Acceptance

• After OGCA inputs NOA information

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

QUESTIONS