STEPS TO STUDY ACTIVATION
Submit Confidential Disclosure Agreement (CDA)
A Confidentiality Agreement (CDA) is a legal document that outlines how confidential information will be handled between the sponsor and the site, and is required for industry studies. It ensures that sensitive information, such as the trial protocol, remains protected from unauthorized disclosure or use. By executing a CDA, both parties agree to maintain confidentiality throughout the trial process. This agreement is essential for fostering trust and collaboration between the sponsor and the site. Principal investigators are not authorized to sign any confidentiality agreements prior to review and negotiation by the appropriate contracting office. Principal Investigators are not a party to the CDA and any agreement that does not obtain the appropriate institutional signatures will be considered invalid. The parties will be negotiated as the sponsor, Trustees of Indiana University, IU Health, Inc. The PI will sign only as read and acknowledged.
CDAs between IU, IU Health and Industry sponsors are reviewed and negotiated by the Office of Clinical Research. Please visit the OCR Contracts page to submit a CDA for review, view answers to frequently asked questions, and find available resources.
- Click the “Request CDA” button on the right-hand side of the page to submit a CDA to the OCR. CDAs are not routed through the KC (Kuali Coeus) Grants system. Please include:
- The investigator and the IU or IU Health department contact information.
- 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).
- Once the CDA has been negotiated and is ready for signature, it will be routed by the OCR via Adobe Acrobat Sign. When prompted to indicate the “reason for signature,” Principal Investigators should respond with “I approve this document,” or even just “Approve.”
- You can view answers to many questions about CDAs by selecting “FAQs: CDAs” in the content shortcuts menu on the right-hand side of the OCR Contracts page.
If you need a CDA and did not receive a draft or template, the OCR has one-way and/or mutual CDA templates available. Click on “Contract Templates & Request Forms” in the content shortcuts menu on the right-hand side of the OCR Contracts Page.
For questions, contact the OCR Contracts team at ocr@iu.edu.
Please note, for non-industry sponsored projects the IU Office for Research Administration’s ORA Contract Request Form should be utilized to initiate the CDA/NDA process. Questions regarding non-industry CDA/NDA review or use of this form should be directed to oraresco@iu.edu.
Submitting a Confidential Disclosure Agreement (CDA) is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.