What is the average review time for clinical trial agreements and CDAs?On average, it takes around 10 business days for the Office of Sponsored Programs and Legal to complete their initial review of clinical trial documents. Once the initial review is completed, it can take from a few days to several weeks to complete negotiations of the contract with the sponsor, depending upon how long the study team and the sponsor take to review and sign off on the documents. Clinical trial budget reviews and negotiations are done simultaneously whenever possible.
Why do I have to complete the Charge Billing Form and who is responsible for obtaining the charges and discounts on that form?The Charge Billing Form is required for all study procedures and physician services that will be paid by the sponsor. The study team is responsible for completing the form up to the CPT codes. After that, the OSP will compare the charge form to the protocol and send to the CDM and Service Analysis team to complete for prices. The CDM team will then send it to Hospital Finance to apply the correct discounts.
The study I'm working on hasn't received IRB approval yet. Will UMMC go ahead and sign the contract?UMMC policy is to hold signature on all research contracts until all applicable assurances have been approved. The OSP staff will review and negotiate your contract and budget in tandem with the IRB review, but we cannot sign until our office has confirmed all assurances are approved or not applicable. We highly encourage you to start the IRB process early and to contact the Human Research Office for assistance to shorten your review time.
What are you looking for during your review of the CTA and budget?All CTAs are reviewed by the OSP and Legal. Each office looks for several items including, but not limited to: Institutional information, governing law, liability, payment terms, record retention, insurance/indemnity, confidentiality, non-compete clauses, privacy laws, notices, reporting and termination.
For clinical trial budgets, the OSP ensures that the sponsor is not being billed over fair market value (FMV) for the services being charged to the study and that the negotiated budget is accurate and covers all expenses including start-up costs, hospital/physician charges, study-specific expenses, labor, closeout costs and F&A costs.
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