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MedStar Health Research Institute (MHRI) was one of the first institutions to register for a new agreement to facilitate faster start-up times for clinical research sites.
MHRI administrative staff has been actively involved in national initiatives to standardize research agreements between clinical research sites and sponsors. In this active role, MHRI has remained on the forefront of finding administrative efficiencies. It is because of this effort that we are proud to be one of the first two institutions to register for the new Federal Demonstration Project Fixed-Price Clinical Trial Sub-Award Agreement. Developed by the National Center for Advancing Translational Science (NCATS) with input from stakeholders, this agreement provides a standard template for federally sponsored multi-center clinical trials involving subcontracting.
With consistent terms and conditions for all studies, the template can lead to faster startup times for new NIH-funded clinical trials. The template is ideal for use with multi-site studies, as it provides a framework for the full contract, except for the study budget and scope of work.
The template was created to be used for NIH-sponsored trials with a fixed price for domestic enrollment sites. The template complies with all federal regulations, adheres to Accelerated Clinical Trials Agreement terms when possible, allows for addition of study-specific terms, and provides budget guidance.
MHRI also is a registered user of the NCATS Accelerated Confidential Disclosure and Accelerated Clinical Trial agreements.
If you have any questions about the Fixed-Price Clinical Trial Sub-Award agreement, please contact Tina Stanger in MHRI’s Office of Contracts and Grants Management at firstname.lastname@example.org.