Clinical Trials Administration Office
The Clinical Trials Administration Office supports the research community with centralized services that include contract and budget negotiations, coverage analysis and reporting. The office also manages the processing of all clinical trial agreements.
Cedars-Sinai requires that a Medicare coverage analysis (MCA) be conducted for any clinical research study that involves billable services (i.e., any clinical service, procedure, an item that can generate a billing charge). MCA is a systematic review of clinical research study documents to determine whether the study is a qualifying clinical trial and to determine which items, procedures and services are billable to Medicare and other third-party payers as routine costs. For medical device studies, the MCA identifies whether the device itself may be billable to Medicare based upon the regulatory status and U.S. Food and Drug Administration categorization of the device and Centers for Medicare and Medicaid Services (CMS) approval status and which items and services required by the protocol may be covered under CMS policies.
The requirement for an MCA applies to all clinical research, regardless of expected inclusion or exclusion of Medicare beneficiaries and source of funding. Every clinical research study must either be determined to be exempt from the MCA requirement as defined in this policy or have an MCA completed prior to Institutional Review Board submission.
Clinical Trials Administration Office works closely with the principal investigator and study team to complete the MCA.
Contract Review and Negotiations
The Clinical Trials Administration Office provides the research community with professional and effective guidance and expertise in processing, negotiating and administering research agreements. This includes drafting, reviewing and negotiating the following agreements:
- Master agreements
- Clinical trial agreements (all funding types)
- Collaboration agreements
- Basic research agreements
- Material transfer agreements (commercial and noncommercial)
- Confidential disclosure agreements
- Data use agreements
- Amendments and modifications to existing contracts
We have developed a 3-part training course that provides an in-depth look at policies, procedures and regulations to prepare new clinical administrators for research at Cedars-Sinai.
Within certain dollar thresholds, Clinical Trials Administration Office 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.
For qualified clinical trials, it's 30% (total direct cost basis). For basic research, it's 75% (modified total direct cost basis), which is the federally negotiated research rate.
Direct costs are all costs that can be readily and specifically identified as benefiting a particular program or project (patient visits, laboratory tests, employee effort, service fees, startup fees, pharmacy fees, etc.). Indirect costs are costs incurred for common or joint objectives. Cedars-Sinai requires that indirect costs be applied to direct costs and fees.
The indirect cost rate recovers actual costs incurred, to provide the facilities and equipment infrastructure as well as administrative costs such as:
- Employee payroll and benefit program administration
- Contract and grant office service
- Purchasing and equipment inventory
- Legal, technology transfer and risk management services required to conduct the project
- The initial IRB Review and Renewal fee recovers 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
- The Study Administrative Startup fee recovers the initial internal costs associated with the administrative startup of new studies using Cedars-Sinai facilities. This includes these study startup activities:
- Initial IRB application prep fee
- Budget development
- Site initiation
- Protocol review
- Feasibility analysis
- $7,000 (plus 30% overhead)—clinical trials phases 1–4, payable on execution of the initial agreement
- $2,500 (plus 30% overhead)—registries/chart reviews/academic collaborations, payable on execution of the initial agreement
- The Pharmacy Startup fee recovers costs associated with the initial study preparation and startup by the pharmacy.
- $1,500 (plus 30% overhead)—non-chemotherapy/noncellular therapies, payable on execution of the initial agreement
- $2,000 (plus 30% overhead)—chemotherapy and cellular therapies, payable on execution of the initial agreement
- Additional fees may be assessed in certain cases based upon requirements and complexities that are determined on a study-specific basis.
Yes, the Clinical Trials Administration Office will accept electronic signatures and digital signatures in a PDF.
Clinical trials at Cedars-Sinai enable research scientists and physicians to discover new treatments and improve patient care and outcomes.
If you have questions or wish to learn more about the Office of Research Administration, please call us or send a message.
6500 Wilshire Blvd., Ste. 1150
Los Angeles, CA 90048