- CDA Checklist
- Why do I need a CDA?
- What if the company says the PI can just sign and return the CDA that it sent to her/him? Is that okay?
- How do I submit my CDA for DSP review?
- What happens after the DSP receives the CDA and Non-Monetary Routing Form?
- What happens after I return the final, PI-signed CDA to the DSP?
- What if the sponsor tells me it does not have a CDA Template?
- How do I check the status of my CDA (e.g., revision process, date submitted to sponsor)?
- Who should I contact if I have questions on completing the CDA/Non-Monetary Routing Form?
Confidential Disclosure Agreements (CDAs) -- also referred to as Confidentiality Agreements and Non-disclosure Agreements -- are binding contracts to safeguard the release or exchange of confidential information.
- Access UIRIS
- In UIRIS complete New MTA & Non-Monetary Agreement Routing Form
- Complete all necessary fields
- Attachments should include CDA in Word Document Format and documents containing specific contact and mailing instructions from the CRO/sponsor
- Submit and Print form
- Obtain signatures as required by your departmental policies
- On the DSP Contract Log, follow the progress of the CDA personnel who was assigned to work on CDA
- PI signs final version of CDA when received from DSP
- Return CDA to DSP (DSP will sign for the University and send to CRO/Sponsor; a PDF of the CDA may be emailed to DSP)
- CRO/Sponsor will send PI the study protocol
- Companies will not send the PI a study protocol and other information about starting a clinical trial unless there is a contract in place in which we promise to keep the information they send us confidential. The role of the Division of Sponsored Programs (DSP) at this stage of the process is to review the CDA terms, negotiate language changes with the study sponsor, and sign for The University of Iowa.
What if the company says the PI can just sign and return the CDA that it sent to her/him? Is that okay?
- No. The PI does not have the authority to sign a contract binding The University of Iowa. Signature authority at the University is limited to a few persons, including the Director of the Division of Sponsored Programs. The PI should sign, acknowledging the terms of the final CDA, but the CDA requires an additional authorized institutional signature from the Division of Sponsored Programs.
As with other types of sponsored-project applications and agreements, CDAs must be routed through UI channels for departmental and collegiate approval before review by DSP. The routing process begins electronically, by completing a form within the University of Iowa Research Information System (UIRIS). Therefore, you must have UIRIS access to submit a CDA for DSP review.
- If you do not yet have UIRIS access, begin here, clicking on the First Time Here/Request Access link and completing the corresponding e-form to obtain a password.
- If you already have UIRIS access, or once you've obtained access, sign into UIRIS.
- Select the Start a NEW MTA & Non-Monetary Agreement Routing
- Answer every item on the electronic form, completing all fields within the Non-Monetary Agreement Information, Mailing Instructions, and Attachments tabs. The following documents must be attached:
- The Word (preferred) or PDF version of the CDA* as received from the sponsor.
- A copy of the email from the sponsor (if available) containing CDA submission/shipping instructions.
- Click Submit at the bottom of the form.
- Print the form.
- Obtain the required signatures from the (a) PI, (b) DEO, and (c) Dean, referring to your own unit's requirements/process for obtaining DEO/Dean signatures.
- Bring/send the fully signed Non-Monetary Routing Form to DSP, 2 Gilmore Hall. Some departments complete this step on your behalf once obtaining required signatures.
DSP will review the original CDA and negotiate appropriate terms with the sponsor as needed. When CDA terms are agreed upon, DSP will send/email a copy to the PI (or research professional working with the PI) for the PI’s signature. Instructions will accompany the final CDA regarding the process for returning the CDA containing the PI’s signature to the DSP.
- DSP will add the authorizing University of Iowa signature and will return the agreement to the sponsor. The sponsor will then have the authority to release the study protocol to the PI and research professional working with the PI.
- Notify DSP and they will send the University of Iowa's model CDA.
- Send an email to email@example.com. Please include the name of the PI and sponsor in your request for an update.
- Call DSP at 335-2123.