Available Services in OnCore

 

OnCore is the current system of record for Coverage Analysis performed on trials conducted at UCSF. OnCore provides a secure, standardized, and reportable database, and permits efficient sharing of protocol information between the Study Team and the Coverage Analyst.  

Effective July 1, 2014, the Office of Research requires all clinical trials and human subject research protocols in which there are medical procedures to have a Coverage Analysis completed in OnCore.

Requesting Services

Services provided by the Office of Clinical Research are requested through the Intake Survey at http://tiny.ucsf.edu/OCRrequest.  The OCR will create a record of your study in the UCSF Clinical Trial Management System, OnCore, create a calendar, perform coverage analysis, and, if applicable negotiate the study budget once all required information has been submitted through the survey.

Before submitting your study for coverage analysis, please ensure that you have the following documentation and information ready:

  • Current version of the protocol.  If a formal protocol is not available, please submit your completed IRB application.  At least one document detailing protocol procedures is required to submit your request.
  • Current version or template of the informed consent form (ICF).
  • IRB number for your study.  The study’s Initial Review with the IRB can be pending.
  • If the OCR will be developing/negotiating your study budget for an industry-sponsored trial, you will need to include a preliminary (or template) contract and budget.
  • To facilitate the coverage analysis and budgeting process, the survey will ask whether you are expecting the study sponsor to pay for all research-related items, services, and procedures OR if any (or all) of these will be billed to the patient or their insurance as conventional care. 
  • In addition, the survey will ask what inpatient and outpatient facilities may be used for research-related clinical procedures.  This information can affect both the coverage analysis and the budget.  It is helpful to review feasibility of your study prior to submitting to the OCR so that your team will have preliminary knowledge of how each procedure will be carried out, by whom, and where.

Frequently Asked Questions:

  1. Can I start my submission and finish it later?

Yes, the intake survey will let you save your progress and return to it later.  However, there are some sections of the survey that you cannot return to once you’ve completed them.  For this reason, we recommend completing the survey in one session.

  1. When should I request Coverage Analysis?

Best practice is to have coverage analysis completed prior to finalizing your study budget, since coverage analysis determinations may affect study costs.  Coverage analysis can be requested concurrently with IRB submissions.

  1. My study is on Amendment 2 of the protocol, but this is our first submission to the OCR.  Do I submit it as a “New Study” or as an “Amendment”?

If your study has not previously had a coverage analysis, please submit it as a “New Study.”  “Amendment” submissions are only for studies that have an existing record and previous Coverage Analysis in the UCSF Clinical Trials Management System (CTMS), OnCore.

  1. What happens after I submit the form?

You will receive a confirmation from the Office of Clinical Research that your submission has been received.  Follow-up information may be requested by the OCR.  Once sufficient information has been received to begin processing your study, you will receive weekly updates on its status.