Clinical Trials Office

FAQ & Help

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Have questions regarding OnCore?
Email OnCore Support:
[email protected]

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To request a group or 1-on-1 training, please email:
[email protected]

Training and Guidance Documents
https://sc-ctsi.org/resources/ctms

Interested in participating in a Clinical Trial?

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FAQs

  • How long soon are initial CTA redlines sent to sponsors after I submit my study in OnCore?

  • Typically between 60 and 90 days for a full negotiation.  If USC has a Master CTA in place with a sponsor or the sponsor is willing to mirror CTA terms from a previous study, then CTA negotiation times can take less than 1 month.

  • Yes – if we have or foresee having numerous studies with that sponsor; however, our preference is to negotiate a standalone CTA once and then mirror those terms for all future studies with that sponsor.  Standalone CTAs are typically negotiated and finalized much faster than the longer timeframes required to finalize Master CTA legal terms.

  • Yes. If sponsors/CROs are taking too long to respond to the CTO’s CTA redlines or are being non-responsive, the contract officer will notify the clinical department, requesting that clinical department/PI follow-up with the sponsor/CRO directly to help move contract negotiations along.

  • No. The contracts team reviews and negotiates only the contract legal terms.  The budget and payment terms are reviewed and negotiated by the CTO budgeting team.

  • Yes. The contracts team reviews and provides ICF language for the Costs, Reimbursement, and Subject Injury Compensation sections of the ICFs used for industry-sponsored interventional and most observational/registry studies.

  • No.  The CTO generally does not review ICFs for compassionate use studies.

  • The IRB checklist process is how the CTO communicates to the clinical department and IRB the Costs, Reimbursement, and Subject Injury Compensation language that should be used in study ICFs.

  • No. The CTO reviews only those ICFs where Costs, Reimbursement, and Subject Injury Compensation are addressed.  Generally, the CTO does not review Pregnant Partner or Future Research ICFs. Please contact the contract officer for your study for clarification/questions on specific ICFs you may have.

  • A study can be placed on hold for numerous reasons; however, the main causes are:

    1. Sponsor non-responsiveness during contract and/or budget negotiations
    2. The CTA has been fully signed but ICFs have not been finalized/approved by sponsors; or
    3. The CTA has been fully signed but a final central IRB approval letter has not been uploaded into OnCore by the clinical department.

    Please review the on-hold reason listed in OnCore, as well as review the OnCore notes for more detail.  Also, always feel free to reach out to the contract officer or budget specialist with any questions you may have regarding an on-hold status.

  • No. It is critical that all CTAs and CDAs are submitted to the CTO or DCG (as applicable) for review and signature, as clinical departments and PIs do not have the legal authority to legally bind USC or to enter into contract terms on USC’s behalf.  Please note this is a critical legal compliance issue.