Contracts

Clinical Trial Agreement

A confidential disclosure Agreement (CDA) is a legal contract that outlines confidential information that may be shared between at least two entities but is not allowed to be shared with third parties.

Confidential Disclosure Agreement

The OCR Contracts Team reviews, negotiates, and executes all industry-sponsored research contracts for Indiana University and IU Health. Although the relationship between IU and IU Health is highly collaborative, they are separate legal entities requiring additional considerations. Whether a trial involves one IU Health site or is statewide, our team is here to help navigate the sometimes complicated legal aspects of research, including identifying the appropriate parties to the contract, determining the correct contract type, negotiating terms, and assisting with contract execution. We negotiate terms such as the following:

    • Indemnification (allocation of risk)
    • Subject injury reimbursement (who is financially responsible in the case of a subject injury)
    • Publications
    • Inventions
    • Confidentiality terms
    • Termination causes and procedures

Feel free to contact us if you have questions regarding research contracting.

Contract Templates/Request Forms

Confidentiality Disclosure Agreement Mutual Template

Download Word Document                    View PDF

Confidentiality Disclosure Agreement One-Way Template

Download Word Document                    View PDF

Clinical Trial Agreement Template

Download Word Document     View PDF

Master Clinical Trial Agreement Template

Download Word Document     View PDF

Investigator-Initiated Trial Agreement Template

Download Word Document     View PDF

Subcontract Agreement Template

Download Word Document     View PDF

 

OCR Subcontract Request Form

Download Word Document     View PDF

Facility Use Agreement Template

Download Word Document     View PDF

 

Letter of Indemnification Template

Download Word Document     View PDF

 

Study Start Up Agreement

Download Word Document     View PDF

FAQs

Confidential Disclosure Agreement

Please submit your CDA requests via the CDA Portal by clicking on the orange button on this webpage.

Please send the editable Word version of the CDA template from the industry sponsor if provided the sponsor’s contact information including name, email address and phone number, please make sure to include the “purpose” of the CDA (typically a protocol # and/or protocol name), the investigator and the IU department contact’s information.

If you are receiving information from the industry sponsor only and not providing any information to the industry sponsor then you will need a one-way CDA.

If you are receiving information from the industry sponsor and you are providing information to the industry sponsor regarding the proposed purpose the you will need a mutual CDA.

Yes, We have both CDA templates which can be found on the OCR website.

Please send your CDA questions to the ocr@iu.edu mailbox.

Please send your CDA questions to the ocr@iu.edu mailbox.

You will receive an email once your CDA has been assigned with your contract officer’s contact information and you will be cc’d on all emails unless you request otherwise.

Clinical Trial Agreement

CTAs can be called clinical study agreements, research study agreements, etc.

317. 278.2546

Indiana University
Attn: Office of Clinical Research
410 W. 10th Street
Suite 1020
Indianapolis, IN 46202

Please send your inquiry to ocr@iu.edu and we can provide you with the W-9 form.

No. The Grants Office in the Office of Research Administration negotiates material transfer agreements.  Please contact them at 317. 274.7925 or view their website.

The OCR negotiates industry sponsored agreements: clinical trials agreements, confidentiality disclosure agreements, master agreements, and subcontracts for clinical trial agreements.

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Trustees of Indiana University

No. As employees of Indiana University conducting research within his/her role as an employee, investigators do not sign OCR contracts as a party..

Indiana University principal investigators sign as employees of Indiana University; therefore, they sign as “Read and Acknowledged.”

No. The Indiana University principal investigator (PI) must sign the contract. No one else in the PI's department can sign the contract in his or her place.

The Trustees of Indiana University
Dept 78945
P.O. BOX 78000
Detroit, MI 48278-0945

Reference:  Protocol #/PI Name

Tax ID: 35-6001673

No. For all account information, please contact Cindy Green in the Office of Research Administration.

For underwrites, please contact Cindy Green in the Office of Research Administration. Accounts may only be underwritten for non-patient related purposes (E.g., ordering supplies, etc.).

Any contract that requires the signature of Indiana University, with the exception of CDAs, needs to be routed.

Only certain individuals have the legal authority to bind Indiana University to obligations with a 3rd party. If the contract is not signed by one of these individuals, the contract will have no binding effect.

Questions regarding contract status can be sent to ocr@iu.edu  or you may call 317.274.CLIN.

See comparison chart here.