FAQs

 

Do CDAs need to be routed?

Please submit your CDA requests via the CDA Portal: https://ocr.iu.edu/investigators-study-coordinators.

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 to 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.

Where can I send general questions about contracts?
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 CRO 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 CRO negotiate?

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

What is the current indirect costs for CRO clinical trials?

30%

What is the legal name for Indiana University?

Trustees of Indiana University

Do Indiana University investigators sign CRO 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 CRO contracts as a party.

If Indiana University principal investigators do not sign CRO 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.”

What does CTA refer to?

Clinical Trial Agreement

What does CDA refer to?

Confidential Disclosure Agreement

What are other names for clinical trial agreement?

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

If the principal investigator is not available to sign a negotiated CRO 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.

Do you have a template that I can send out to a sponsor?

Yes. Any changes to these contracts must be reviewed by the CRO. To find the templates, please click Contract Templates.

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 of 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.

How is an industry-sponsored clinical trial and an investigator-initiated clinical trial similar? How are they different?

See comparison chart here.