OCTA CDA & Amendment Request Form

OCTA CDA & Amendment Request Form
Please specify your request?
Please use the Emergency Use/Compassionate Use form to submit your request!
- Is the attached Site Agreement ready to be signed by OCTA “as-is”?
- If no, please explain what OCTA is requested to review:
- This form is for completion by a UCSD Department to upload the final service agreement budget (“PSA Budget”) that has been approved between the UCSD Department and Rady Children’s Hospital of San Diego in connection with an industry clinical trial agreement processed through OCTA. I confirm this service agreement budget is final and approved, and can be incorporated into the PSA by OCTA and routed for signatures.
- 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.
- Is this CDA/NDA intended to govern the sharing of information for the purpose of evaluating (a) the feasibility of UCSD’s participation in a for-profit, industry authored and 100% for profit, industry funded clinical trial Protocol or (b) a similar human subjects research project that is for-profit initiated and 100% for-profit funded?
- Please indicate whether ALL of the following statements are true: (a) The primary intent of this CDA request is only for the company to share proprietary information with UCSD. (b) The CDA does not contemplate or anticipate a collaborative or UC PI initiated project that involves intellectual investment of UC. (c) Tangible research materials will not be transferred under this CDA.
- 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.
- Form Preparer Name
  
  First NameLast Name
- Preparer Email
  example@example.com
- PI First Name
- PI Last Name
- PI Combined Name
- PI Email
  example@example.com
- PI Department
- Note: If your particular department is not listed above, please contact OCTA@health.ucsd.edu for further assistance!
- Sponsor Name
  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.
- Prime Sponsor Name
  If you entered the name of a CRO or ACC above, enter the for-profit, industry sponsor’s name here.
- Sponsor Protocol #
- Sponsor Contact Person
  
  First NameLast Name
- Sponsor Contact Email
  example@example.com
- Sponsor Contact Phone
  
  Area CodePhone Number
- Prime Sponsor Contact Person
  
  First NameLast Name
- Prime Sponsor Contact Email
  example@example.com
- Prime Contact Phone
  
  Area CodePhone Number
- Department Study Coordinator Name
  
  First NameLast Name
- Study Coordinator Email
  example@example.com
- Study Coordinator Phone
  
  Area CodePhone Number
- UCSD Department Contact Name
  
  First NameLast Name
- UCSD Department Contact Email
  example@example.com
- Has the proposed change to the PSA been reviewed and approved by the UCSD Department?
- Please provide additional details or comments as helpful or necessary for OCTA to understand the scope and/or intended purpose of the CDA/NDA.
- 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).
- Protocol Title
- Protocol Name or #
  Max. 80 characters
- Product Name
  Max. 80 characters
- Disease/Indication
  Max. 80 characters
- If no Protocol Title or Name exists yet and/or if there is no investigational product to identify, provide details about the purpose of the proposed project/program, UCSD/PI’srole, and the area of research this CDA is intended to cover.
- Will export controlled information, materials (e.g. toxins), or software be sent or received under this CDA/NDA?
- Please provide details:
- Has Sponsor provided a CDA/NDA template for UCSD’s review?
- Please attach CDA/NDA template.
  
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- If no template is provided, OCTA will send Sponsor a draft template.
- Amendment Purpose (check all that apply):
- Amendment Purpose (transfer only)
- PI Change
- New PI Name
  
  First NameLast Name
- New PI Department
- 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.
- Confirm PI Eligibility:
- Please attach completed PI Exception Form:
  
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- Confirm COI Status:
- Industry Sponsor Change/Assignment
- New Industry Sponsor Name
- New Industry Sponsor Address
- New Industry Sponsor Contact Name
- New Industry Sponsor Contact Email
  example@example.com
- New Industry Sponsor Contact Phone
- Has the Industry Sponsor provided a notice of transfer or notice of assignment or similar document?
- Please attach document:
  
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- CRO Change/Assignment
- New CRO Name
- New CRO Address
- New CRO Contact Person
- New CRO Contact Email
  example@example.com
- New CRO Contact Phone
- Budget Increase
- Why is the budget changing (increase)? (select all that apply)
  
  Other
- 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).
- Estimated Budget Increase
  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.
- Budget Decrease
- Why is the budget changing (decrease)? (select all that apply)
  
  Other
- 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).
- Estimated Budget Decrease
  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.
- Who is responsible for negotiating the budget change (increase/decrease)?
- 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.
- Budget Negotiator Name
- Budget Negotiator Email
  example@example.com
- Budget Negotiator Phone
- 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
- New Completion or Study End date
  
  MonthDayYear
  Date
- 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.
- Please explain the reason for the No Cost Extension:
- Other Change in Contract Terms
- Please provide further explanation of changing terms:
- Does the amendment require IRB Approval?
- Confirm status of IRB approval
- Proposal #
  For older contracts with only an IP#, enter “00000” to bypass the Proposal # field. In this case, an IP# must be provided.
- Institutional Proposal #
  Enter “00000” to bypass the Institutional Proposal # field. In this case, an Award # must be provided.
- Award #
- IRB #
  Example: 129074 (6 digits only)
- Amendment #
- Has Sponsor provided an Amendment template for UCSD’s review?
- Please attach Amendment template.
  
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- If no template is provided, OCTA will send Sponsor a draft template.
- Please provide any additional details or comments as helpful or necessary to OCTA’s review and processing of this Amendment:
- Please attach supporting documents.
  
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- Please attach final and approved PSA Budget.
  
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- Additional Comments:
- Site Name
- Site Contact Name
- Site Contact Email
  example@example.com
- Please attach Site Agreement.
  
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- Additional Comments:
- Submission Date
  
  YearMonthDay
  DateHourMinutesAM/PM Option
- Contact Name
- Contact Email
  example@example.com
- OCAA Email
  example@example.com
- For assistance requesting the review of Clinical Trial Agreements, Expanded Access Agreements, or other contracts please email octa@health.ucsd.edu.
- Should be Empty: