How It Began
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 sub-award for clinical trials. This need was echoed by in March of 2015 by the FDP (Federal Demonstration Partnership). In June of 2015, the federal sub-award work group began the development of a master agreement with representatives from the CTSA Institutions 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
– Domestic enrolling sites only
– Comply with all federal regulations
– Adhere to ACTA terms whenever possible
– Allow study specific terms to be added
– Create budget guidance
The sub-award was officially approved for use by the CTSA stakeholders, the NIH, and the FDP in August 2016.