Review the Coverage Analysis Policy and Coverage Analysis page of our website. The Coverage Analysis Determination Form is COMING SOON. If you need more help, please email [email protected].

• If the study requires a Coverage Analysis, proceed with Step 2. Submit to OCTA.

• If the study does NOT require a Coverage Analysis:

This is considered a non-clinical research billing (non-CRB) study since study-required activities will not generate charges in APeX/Epic. You are not required to submit this study to OCTA. For additional services:

• OnCore Calendar Build Services Only
  • If you plan on tracking study participants in OnCore, please contact [email protected] and indicate you are requesting calendar build services only. Please be sure to provide your Submission ID generated from the Coverage Analysis Determination Form.
• Non-CRB APeX Study Builds
  • Please submit an APeX Study Request Form. Please note that you will be required to provide an Award Number/Chart String/Chart of Accounts (COA).
•  Budgeting Services
  • Please visit the Budgeting section on our website.

Clinical Trials Activation Request Form

Required documents for submission to OCTA:

Additional recommended information for submission to OCTA:

• Data Safety Monitoring Committee Charter
• IND/IDE FDA May Proceed Letters
• Investigator's Brochure
• Lab, Imaging, Pharmacy, and other applicable manuals
• Sponsor and CRO Contacts

There are three methods to locate the activation status of your study within OCTA:

• Use the Current Activation Pipeline Dashboard to track progress and status.
  • Using your UCSF My Access Credentials, find details on this and other OCTA dashboards, how to gain access and training quick guides at OCTA Tableau Dashboards - OnCore Wiki - Wiki@UCSF.
• Review the OCTA Task List in OnCore.
• Email the OCTA Operations Team at [email protected]. 

The Principal Investigator and Study Team will be required to review and approve the Coverage Analysis and Budget before moving forward. If OCTA is not providing budget serivces, the Study Team will only review the Coverage Analysis.

• Coverage Analysis and Internal Budget Review Guide
• More on Coverage Analysis
• More on Budgeting

Required Documents for OCTA Finalization:

• IRB Approval Letter
• IRB Approved Protocol
  • NOTE: OCTA cannot finalize if the IRB approved protocol version is different than the protocol version submitted to OCTA
• IRB Approved Consent Form(s)
  • NOTE: If using the UCSF IRB, ensure your ICF cost language meets UCSF standards prior to receiving IRB approval. If you have any questions or need additional assistance with your ICF cost language, please contact our OCTA Quality Improvement & Compliance Officer, Jeanna Julo. If using consent forms in non-UCSF format, follow HRPP guidance.

If UCSF IRB reviewed, OCTA will obtain final documents in iRIS.

If external IRB reviewed, please provide OCTA with the above approved documents, and ensure the UCSF IRB has acknowledged the reliance.

• Principal Investigator to complete 700U and/or Policy 11 Conflict of Interest form in DocuSign, see FAQ.
• Principal Investigator and Department Chair to review & approve in eProposal, see eProposal Quick Guide for Approving Proposals.
• OCTA will notify the Industry Contracts Division to proceed with contract execution.
• More on Financial Conflict of Interest in Research.

The Office of Sponsored Research, Industry Contracts Division Officer will negotiate and perform the final contract execution.

• For industry sponsored studies, OCTA will submit to Industry Contracts Division on your behalf for contract review and execution.
• For non-industry sponsored studies, please contact Office of Sponsored Research for budget and contract services.

To locate the ICD Officer assigned to your study, please view the Staff List in the OnCore PC Console, using this quick guide. For questions about the contract please contact [email protected].

Prior to requesting an APeX study build, be sure that:

If the study requires a Coverage Analysis:

• OCTA has finalized your coverage analysis
• IRB Approval information is recorded in the OnCore protocol record
• Consent Form details are recorded in the OnCore protocol record
• Accurate institutions and study sites are entered into OnCore
• Contracts and Grants Accounting (CGA) has provided an Award Number/Chart String/Chart of Accounts (COA)

If the study does NOT require a Coverage Analysis:

• You request a non-clinical research billing APeX study build
• Please note that you will be required to provide an Award Number/Chart String/Chart of Accounts (COA)

Then use this form to request an APeX study build:

APeX Study Request

Prior to enrolling study participants, ensure the OnCore protocol record is up to date and open to accrual.

• Update Staff List
• Update Study Sites
• Document IRB reviews in OnCore
• Document IRB approved consent forms in OnCore
• Open study to Accrual

Clinical Trials Activation Request Form

When submitting a protocol amendment to the UCSF or external IRB, also submit to OCTA. Study protocol or budget amendments often require an update to the IRB application, consent forms, OnCore calendar, coverage analysis, and/or budget. Begin at step #2 and submit amended documents to OCTA to initiate updates to the OnCore calendar build, coverage analysis, budget and contract.

Required Documents for OCTA Amendments: