Amendments and CTA Extension of Time

Clinical Trial Amendments

An amendment changes the terms of a previously executed agreement. Amendments may be monetary, non-monetary or both. Amendments to CTA’s must be reviewed, approved and executed by the legal authorities at the Division of Sponsored Programs (DSP).

DSP Process for Clinical Study Agreement (CSA) Amendments:

If the Clinical Study (human subject research with clinical services at the HSC) has been approved in UFIRST Proposal Module based on sponsor’s per-patient budget and a zero-dollar detailed budget and the related CSA has been fully executed in the UFIRST Agreement Module, the CSA can be amended without creating a new UFIRST Proposal. (see Notes 1 and 2 below):

Note 1: A new UFIRST Proposal will be created when the sponsor presents a new protocol and/or when a new IRB number is required.

Note 2: Per standard practice, RAC staff will upload the CSA amendment in the UFIRST Agreement Module and process it appropriately, with compliance paperwork reviewed and approved as applicable, before DSP signs for UF.

Clinical Trial Extensions

Upon request or notification to DSP’s Award Administration Office at internal extensions for clinical trials can be granted to accommodate an administrative close of a trial, generally a 3-month period, where no further human subject activity will take place.

All other extensions would require sponsor approval by a clinical trial amendment.