Clinical Trials Administration Office
The Clinical Trials Administration Office supports the research community with management of the processing of all clinical trial agreements as well as centralized services that include budget compliance review, coverage analysis and reporting.
Cedars-Sinai requires that a coverage analysis (CA) is performed for any clinical research study that involves billable services (i.e., any clinical service, procedure or item that can generate a billing charge). The CA is a systematic review of clinical research study documents and determines whether the study is a qualifying clinical trial and which items, procedures and services are billable to Medicare and other third-party payers. The CA is conducted in compliance with the federal Clinical Trials Policy and is applied universally, regardless of the study’s funding source. For medical device studies, a CA determines whether the study device is billable based upon the U.S. Food and Drug Administration’s determination of the device’s regulatory status. For study devices conducted under an investigational device exemption (IDE), the CA ensures that the Centers for Medicare and Medicaid Services (CMS) has issued approval for billing of the investigational device and associated routine costs.
The requirement for CA applies to all clinical research studies, regardless of expected inclusion or exclusion of Medicare beneficiaries and the source of funding. Every clinical research study is reviewed to determine whether it is exempt from a CA or should have a CA completed prior to Institutional Review Board submission.
The Clinical Trials Administration Office works closely with the principal investigator and study team to complete the CA.
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:
- Clinical Trial Agreements
- Master Agreements (with industry partners)
- Collaboration Agreements (with industry partners)
- Compassionate Use/Extended Access Agreements (with industry partners)
- Confidential Disclosure Agreements (research-related, when Cedars-Sinai Medical Center is disclosing)
- Core Lab Services Agreements (if Cedars-Sinai Medical Center is participating in the related trial)
- Data Use Agreements (with industry partners)
- Material Transfer Agreements (with industry partners)
- Memos of Understanding (research-related, with industry partners)
- National PI Agreements (with industry partners)
- Research Grant Agreements (with industry partners)
- Sponsored Research Agreements (basic/non-human with industry partners)
- Subcontracts/Subawards (with industry partners)
- Amendments to existing agreements within CTAO scope
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.
Frequently Asked Questions
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
Effective September 1, 2014, Cedars-Sinai Medical Center adopted DocuSign as the approved electronic signature system for the execution of all contracts processed through the Office of Research Administration/Clinical Trials Administration Office. “Wet” signatures will no longer be obtained. Cedars-Sinai has the highest standards for selecting and implementing technology solutions and our Enterprise Information Services (EIS) leadership has found DocuSign to meet our standards for security and legal enforceability. Electronic signatures through DocuSign are court admissible and have been legally recognized for the last 20 years with the adoption of the Uniform Electronic Transactions Act (UETA) and the passage of the Electronic Signatures in Global and National Commerce Act (ESIGN).
Clinical trials at Cedars-Sinai enable research scientists and physicians to discover new treatments and improve patient care and outcomes.
Office of Research Administration
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