OCAA Clinical Trial Budget Service Request Form

OCAA Clinical Trial Budget Service Request Form
OCAA offers budgeting services for industry initiated clinical trials. With the increasing costs and demand of clinical trials, our team offers full concierge services to execute your study budgets and to enhance your experience with the study sponsor. We will develop a detailed budget and negotiate the figures with the sponsor to ensure the sponsor covers the full cost of conducting the study at UCSD.

BUDGET SERVICE SUBMISSION CHECKLIST:
- All "NEW" budgets require:
  - New UCSD Proposal number from Kuali Research
  - Upload of study protocol, ICF or draft, and sponsor budget template
- All "AMENDMENT" budgets require:
  - CTA amendment requests through the OCTA online form
  - IRB number
  - Upload of study protocol, tracked changes version of protocol, and sponsor budget template
For more information visit our website https://medschool.ucsd.edu/vchs/research-services/clinical-research/ocaa/Pages/default.aspx.

Contact Us: Tel: (858) 534-4761 or email OCAA@health.ucsd.edu
Is your clinical trial 100% industry (for profit) funded?*

YesNo
We're sorry, at this time our service does not support your clinical trial. For more information, please contact OCAA@health.ucsd.edu.
Department:*

ANESTHESIOLOGYCANCER CENTERCARDIOVASCULARDERMATOLOGYEMERGENCY MEDICINEENDOCRINOLOGYGASTROENTEROLOGYHEMATOLOGYHEPATOLOGYCANCER CENTERNEPHROLOGYNEUROSCIENCEOPHTHALMOLOGYORTHOPEDIC SURGERYPEDIATRICSPSYCHIATRYPULMONOLOGYRHEUMATOLOGYSURGERYUROLOGYOther
Type of Request:*

New BudgetBudget Amendment
Tracking Type (utility only)
Charge Amount (utility only)
Have you submitted an amendment request to OCTA for your CTA?*

YesNo
In order to complete your budget request submission, you must first submit an amendment to the CTA. Please visit OCTA’s website to submit an amendment request.
Does this amendment require a change to the coverage analysis?*

YesNo
Please submit a request for coverage analysis review in Kuali Protocols.

...
UCSD Kuali Proposal Number:*
PI First Name*
PI Last Name*
PI Combined Name
IRB Number:*
Should be between 1 - 999999
Reason for Budget Amendment?*

There was a protocol amendment.Study team is spending more time than budgeted.Institutional research rates were increased.Research rates in my budget are too low.I have missing procedures in my budget.
What is the version of the protocol amendment?*
What are the specific changes you are requesting?*
Submitter Name*

First NameLast Name
Submitter Email*
example@example.com
Sponsor Name:*
Sponsor Protocol Number:*
Protocol Version and Date:*
Sponsor Contact Person:*

First NameLast Name
Sponsor Contact Email:*
example@example.com
Will the Sponsor use a CRO?*

YesNo
CRO Name:*

COVANCEICONIQVIAMEDPACEPAREXELPPDPRASYNEOSWORLDWIDEOther
CRO Contact Person*

First NameLast Name
CRO Contact Email*
example@example.com
Is Investigational Drug Services (IDS) required?*

YesNo
Will ACTRI services be used?*

YesNoMaybe
Please check all services to be used:*

Clinic UseResearch CoordinatorIDS PharmacyProject ManagementRegulatory Support
UCSD Study Team Contact Person*

First NameLast Name
UCSD Study Team Contact Email*
example@example.com
Please upload the study protocol:

Browse Files

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Please upload the tracked changes version of the protocol:

Browse Files

Cancelof
Please upload the sponsor budget template:

Browse Files

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Please upload the informed consent form (ICF):

Browse Files

Cancelof
Please upload other relevant documents (pharmacy manual, surgical manual):

Browse Files

Cancelof

ACTRI Backup Chartstring Agreement (click to expand)
ACTRI Backup Chartstring Agreement

General Approach

Backup chartstrings will be treated differently from actual chartstrings during the billing process. Any service recharges associated with a backup chartstring will be held back for the duration of up to one (1) year from the date of the first recharge service provided. During this one-year grace period, the PI has the opportunity and obligation to provide an actual chartstring (once available) to ACTRI Finance. If, after one year, no actual (and valid*) chartstring has been provided by the PI, ACTRI Finance will proceed with charging any outstanding balances from services rendered to the backup chartstring. Any subsequent internal fund transfers will be the responsibility of the fund manager of the PI’s home department.

Backup chartstrings were implemented to accommodate PIs whose studies have not been awarded funds yet due to ongoing contract and/or budget negotiations. However, the obligation to settle any outstanding balances is independent from the successful initiation/execution of a given study/contract. PIs will be charged any outstanding balances from services received either (a) upon provision of an actual chartstring during the one-year grace period or (b) upon expiration of the one-year grace period, using the backup chartstring.

At ACTRI’s sole discretion, the one-year grace period may be extended in case of any additional contracting and/or budgeting delays that are outside of the PI’s control.

Site Qualification Management Exception

All site qualification management services will be automatically recharged six (6) months after service provision, regardless of whether the site was selected or not. Any related IRB submission services will be recharged in accordance with the general approach specified above.

*) ‘Valid’ means the chartstring is active and chargeable, and the service dates would fall within the start and end date of the chartstring of the fund.

For additional details on ACTRI Terms and Conditions for Support, click here.

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OCAA Clinical Trial Budget Service Request Form

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