Industry Sponsored Research Frequently Asked Questions
What steps should I take to begin industry/Cedars-Sinai collaborations?
- Enter into a CDA — ISRO can work with you to put a CDA in place.
- Internal documents may be required to begin research agreement review.
- Contact Angela Lorenzo (email@example.com) to initiate all new agreements.
- An assigned industry contract officer will work with the faculty and industry partners to establish appropriate research agreements.
Who can sign research contracts on behalf of Cedars-Sinai?
Within certain dollar thresholds, ISRO Grant and Contract Officers can execute certain agreements with for-profit/industry sponsors. For agreements that exceed these dollar thresholds, signature routing will go through the office of the Vice President for Research.
What is Cedars-Sinai's Facilities and Administration rate for Industry Sponsored Research?
- Qualified clinical trials — 30 percent total direct cost basis (TDC)
- Basic research — 75 percent modified total direct cost basis (MTDC) Note: This is the federally negotiated research rate.
What costs are incorporated into the F&A rate?
Direct costs are defined as all costs that can be readily and specifically identified with benefiting a particular program or project (i.e., patient visits, laboratory tests, employee effort, service fees, startup fees, pharmacy fees, etc.). Indirect costs are defined as costs that are incurred for common or joint objectives. Cedars-Sinai requires that indirect costs be applied to direct costs and fees.
The indirect cost rate is calculated to recover actual costs incurred to provide the facilities and equipment infrastructure as well as administrative costs such as accounting, employee payroll and benefit program administration, contract and grant office services, purchasing and equipment inventory, and legal, technology transfer and risk management services required to conduct the project.
Does Cedars-Sinai have a policy requiring established startup fees to recover the cost of initiating clinical trials?
Yes. The fees are as follows:
- Initial IRB Review and Renewal Fee
To recover the IRB costs associated with the initial review of new clinical trial submissions and related renewals/amendments. This fee is a one-time IRB fee that will cover the life of the clinical trial.
- $3,000, payable upon execution of initial agreement
- Study Administrative Startup Fee
To recover the initial internal costs associated with the administrative startup of new studies using Cedars-Sinai facilities.
Fees include, but are not limited to, the following study startup activities:
- Initial IRB application prep fee
- Budget development
- Site initiation
- Protocol review
- Feasibility analysis
- $7,000 (plus 30 percent overhead) — clinical trials phase 1-4, payable upon execution of initial agreement.
- $2,500 (plus 30 percent overhead) — registries/chart reviews/academic collaborations, payable upon execution of initial agreement.
- Pharmacy Startup Fee
To recover costs associated with the initial study preparation and startup by the pharmacy.
- $1,500 (plus 30 percent overhead) — nonchemotherapy/noncellular therapies, payable upon execution of initial agreement.
- $2,000 (plus 30 percent overhead) — chemotherapy and cellular therapies, payable upon execution of initial agreement.
Additional fees may be assessed in certain cases based upon requirements and complexities that are determined on a study-specific basis.
Where can I find Cedars-Sinai Industry Sponsored Research template agreements?
Please contact the assigned contract officer for the medical department/division listed within the Contacts section of this site, and the officer will work with you to identify the appropriate forms and/or template agreements. If you don’t know whom to contact, please direct your question to Angela Lorenzo (firstname.lastname@example.org).
Does Cedars-Sinai accept electronic signatures for the execution of Industry Sponsored Research contracts?
Yes, the Industry Sponsored Research Office (ISRO) will accept electronic signatures, as well as PDF signatures. ISRO utilizes DocuSign as its e-signature system, but will also consider use of other e-signature systems adopted by industry sponsors.