Unlike the other agreements, this option uses a template agreement. This means that there isn’t any one agreement that all parties sign onto. Instead, the template serves as a mutually agreed-upon starting point when a study does not fit within the standard agreement options of the gDSSA, gPSA, gPSA-Unregulated. It is most appropriate for studies funded by organizations with unique or non-standard requirements, where additional customization of terms is needed to support the project. This template serves as a practical starting point, incorporating flexibility to accommodate varying trial scenarios (e.g., investigational products, indemnification).
This tool is designed to uphold pre-negotiated terms and conditions where appropriate while allowing customization when needed.
