In early 2015, the National Center for Advancing Translational Science (NCATS), in conjunction with the Clinical and Translational Science Award (CTSA) leadership, identified a need for a federal subaward for clinical trials. This need was echoed in March 2015 by the FDP (Federal Demonstration Partnership). In June of 2015, the federal subaward working group began the development of a standard agreement with representatives from the CTSA Hubs and FDP Member Institutions. The goal was to create a sub-award template for federally funded clinical trials that most domestic institutions could accept negating the need for tedious negotiations.
The work group created the agreement using the premises of:
- An NIH sponsor
- Fixed Price (future work will address a cost-reimbursable agreement)
- Domestic enrolling sites only
- Comply with all federal regulations
- Adhere to ACTA (Accelerated Clinical Trials Agreement) terms whenever possible
- Allow study specific terms to be added
The subaward was officially approved for use by the CTSA stakeholders, the NIH, and the FDP in August 2016. The Trial Innovation Network has adopted this agreement with Network specific updates to Attachment 2B and is calling the agreement the FDP-CTSA Trial Innovation Network Standard Agreement.
FDP-CTSA Standard Agreement Toolbox
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