Before submitting a contract to OCTA, please ensure that the activity the contract intends to cover meets the following criteria:
- The study protocol is developed or authored by a for-profit, industry sponsor (No UC PI authorship); The industry sponsor is the regulatory sponsor
- The study is funded with 100% for-profit, industry funds; and
- The proposed study activity is research involving human subjects.
Please email OCTA@health.ucsd.edu if you have questions or are unsure if OCTA is the right office to negotiate your agreement. We are happy to help guide your contract request to the appropriate central office.
OCTA relies on the accuracy and the completeness of information provided through the contract submission channels described below. This helps us provide prompt and effective customer service.
Clinical trial agreements are to be submitted as new proposals in Kuali Research.
The following PDF guide and training videos provide step-by-step instruction for preparing and submitting a proposal to OCTA in Kuali Research for a clinical trial agreement.
CDA/NDA's are to be submitted using the form link below. Select "CDA/NDA" to initiate your request.
Contract amendments are to be submitted using the form link below. Select "Contract Amendment" to initiate your request.
Emergency Use or Compassionate Use agreements are to be submitted using the form link below. Select "Emergency Use/Compassionate Use" to initiate your request.
Please Note: This form is intended for unfunded Emergency Use/Compassionate Use contract review requests to facilitate a UCSD PI obtaining expanded access to an investigational drug or device for the purpose of diagnosing, monitoring, or treating a UCSD patient's disease or condition rather than to conduct research and obtain information and data that is generally derived from a clinical trial. If you have questions, please contact OCTA@health.ucsd.edu.