OCTA CDA & Amendment Request Form

CDA/NDAContract AmendmentPSA Budget (Rady Children's Hospital Only)PSA Amendment (Rady Children's Hospital Only)CHAT Consortium Site AgreementEmergency Use/Compassionate Use

Please use the Emergency Use/Compassionate Use form to submit your request!

Please obtain approval by all parties and re-submit once this budget can be considered final and approved. For questions, please contact OCTA@health.ucsd.edu.

CDA/NDAs for PI Initiated, collaborative, or non-industry funded research projects (including mixed funding) or for the transfer of materials should be submitted to the Office of Contract and Grant Administration (OCGAContractSupport@ucsd.edu). If you require further assistance, please contact OCTA@health.ucsd.edu.

Note: If your particular department is not listed above, please contact OCTA@health.ucsd.edu for further assistance!

If the original contracting party is a clinical research organization (CRO) or academic coordinating center (ACC), enter that party’s name here. Otherwise, enter the name of the for-profit industry sponsor.

If you entered the name of a CRO or ACC above, enter the for-profit, industry sponsor’s name here.

Area CodePhone Number

Please provide the information requested below for all fields that apply to the project this CDA is intended to cover. If responses are minimal or unclear, you will be contacted by an OCTA Contract Officer to collect and provide additional information (you must provide at least one study identifier to complete this request).

YesNo, sponsor is requesting UCSD to provide a template

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If no template is provided, OCTA will send Sponsor a draft template.

Note: If your particular department is not listed above, please contact OCTA@health.ucsd.edu for further assistance!

Note: Starting June 15, 2020 all PI Exception requests (PIE) should be submitted through OnBase. Find more information about this new process and PI eligibility on blink or contact piexceptions@ucsd.edu.

PI is EligibleException Form

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PI has submitted 700-U FormPI will submit 700-U Form

Industry Sponsor Change/Assignment

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CRO Change/Assignment

Protocol AmendmentBudget does not capture all study activityVisit or procedure costs have increasedOther

If known, please provide the total estimated dollar value increase this Amendment will result in, assuming the proposed changes apply to all enrollees (i.e. by approximately how much will the total study budget increase, as a result of full implementation of this amendment).

NOTE: If this information is not known at the time of Amendment submission, it will need to be provided to your contract officer at the time of contract execution.

Protocol AmendmentVisit or procedure costs have decreasedReduced enrollment or scope of participationOther

If known, please provide the total estimated dollar value decrease this Amendment will result in, assuming the proposed changes apply to all enrollees (i.e. by approximately how much will the total study budget decrease, as a result of full implementation of this amendment).

NOTE: If this information is not known at the time of Amendment submission, it will need to be provided to your contract officer at the time of contract execution.

PI/DepartmentOCAA Budget ServicesACTRIRSC

Note: OCTA is not responsible for reviewing or negotiating budget figures. The PI is responsible for reviewing, negotiating, and approving all proposed budget figures and related terms or designating this responsibility to another person in the Department or requesting help from a central service such as OCAA.

If you have not already done so, please email OCAA@health.ucsd.edu to request budget negotiation services for your Amendment. It is your responsibility to communicate directly with OCAA to initiate this request and confirm that OCAA will negotiate the amended budget terms.

No Cost Extension

Note: This type of amendment only applies to contracts with an explicit study completion or end date that requires a formal amendment to extend the study completion or end date listed in the contract.

Other Change in Contract Terms

Not submittedPending approvalApproved

For older contracts with only an IP#, enter “00000” to bypass the Proposal # field. In this case, an IP# must be provided.

Enter “00000” to bypass the Institutional Proposal # field. In this case, an Award # must be provided.

Example: 129074 (6 digits only)

YesNo, sponsor is requesting UCSD to provide a template

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If no template is provided, OCTA will send Sponsor a draft template.

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DateHourMinutesAM/PM Option

For assistance requesting the review of Clinical Trial Agreements, Expanded Access Agreements, or other contracts please email octa@health.ucsd.edu.