We have increased our study fees for cancer industry-sponsored studies to more closely align with the amount of effort it takes to do the work. These modified fees will be included in new industry study budgets negotiated by CCTO-Finance starting on 1 September 2018. If the budget is already in negotiation, new fees will not be used.
Effective March 7, 2018, the Clinical & Translational Research Unit has corrected the service description for service line items ‘CM001’ and ‘I-CM001’ | “Infusion time, base” for both non-industry and industry studies to reflect that is does not include “IV Placement/Central Line Access”. All studies requiring infusions must also include ‘CG003’ or ‘I-CG003’ into their budgets, as they will be invoiced for IV placements/Central Line Access. Studies that were approved and/or activated in the CTRU budget builder website between July 1, 2017 and March 7, 2018 will not be billed for service line item ‘CG003’ or ‘I-CG003’ through the entirety of those specific research projects. This will be voided if the study rebudgets for any of the reasons covered in the CTRU Subsidy and Cost Recovery Policy 2017.
This does not apply to studies:
- Approved and/or activated prior to July 1, 2017 and not submitted through the CTRU Budget Builder website.
- Approved and/or activated after March 7, 2018
For questions and requests, please contact email@example.com and the team will be happy to assist you.
The Regulatory FAQs have been updated on the CCTO website. Get answers to the most commonly asked regulatory questions at the link: http://med.stanford.edu/ccto/services/regulatory.html#faqs
The IRB has recently issued a guidance document on the pregnant partner consent process. You can view the document at: http://humansubjects.stanford.edu/research/documents/pregpart_GUI-C47.pdf
RMG/CCTO has developed a new workflow process for use of PHI for complex procedure pricing to ensure minimum necessary access to PHI. The new documents can be found at Coordinator Corner:
- Complex Procedure Pricing Workflow
- Complex Procedure Pricing Information
- Process for Requesting Hospital Billing Information
In order to approximate a reasonable estimate of hospital charges for a complex procedure, RMG/CCTO requires the assistance of the study team and Patient Financial Services (PFS) to identify previous examples upon which we can develop a reasonable estimate. This is an operational business need.
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