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Contracts

  • CDAs and CTAs made easy for all researchers

Confidential Disclosure Agreement (CDA)

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.

OCR Contracts require a fully executed Confidentiality Agreement (CDA) to accompany all new Clinical Trial Agreement (CTA) submissions. Principal investigators should not be engaged in study-related discussions with third parties unless a CDA is in place.

Principal investigators are not authorized to sign any confidentiality agreements prior to review and negotiation by the appropriate contracting office. 

Guidelines to Determine Appropriate Contracting Office at IU

Clinical Trial Agreement (CTA)

The OCR Contracts Team reviews, negotiates, and executes all industry-funded 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

Confidential Disclosure Agreements
Clinical Trial Agreements
Subcontractor Forms
Other

FAQs

Confidential Disclosure Agreements

What is a CDA?

Confidential Disclosure Agreement

Do CDAs need to be routed?

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

What information is needed when submitting a CDA to the Office of Clinical Research mailbox?

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.

Do I need a one-way CDA template?

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.

Do I need a mutual CDA template?

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.

Does IU have a one-way and/or mutual CDA template to provide to industry sponsors if the sponsor did not provide one initially?

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

Where can I send questions regarding CDAs?

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

How will I know when my CDA is being worked on by a contract officer?

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 Agreements

What is a CTA?

Clinical Trial Agreement

What are other names for a clinical trial agreement?

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

Other

Where can I send general questions about contracts?

ocr@iu.edu

Is there a phone number I can call to get in contact with the OCR?

317. 278.2546

What is the OCR address?

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

My industry sponsor is requesting a W-9 form, where can I obtain a copy?

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

Does the OCR negotiate material transfer agreements?

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.

What types of contracts does the OCR negotiate?

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

What is the current indirect costs for OCR clinical trials?

36%

Trustees of Indiana University

Do Indiana University investigators sign OCR contracts as a party to the agreement?

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

If Indiana University principal investigators do not sign OCR contracts as parties, what do they sign as?

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

If the principal investigator is not available to sign a negotiated OCR contract, can someone else sign on his/her behalf?

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.

To whom should payment checks be made and what is the address for payments?

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

Reference:  Protocol #/PI Name

Tax ID: 35-6001673

Does your office handle clinical trial accounts?

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

What if I need to open an account before the contract is finished?

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

What needs to be routed?

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

Why can't I just sign the contract?

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.

How can I check on the status of my contract?

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

CONTENT SHORTCUTS

Request CDA
Route CTA to OCR

Exclusively for IU Health Investigators:

Submit IU Health Contract
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