The instructions provided in the document with the title above in the subsection of the Agency’s website – Good Clinical Practice,GCP – (Clinical trials subject to US regulations) have the following specifications:

  • cut off date – 30.04.2025. (date from which the change in the local procedure is considered)
  • The transition period for adaptation intended for the CRO/sponsor is 2 months
  • The date of the procedure change refers to the date of signing the FDA 1572, and not to the date of study approval
  • Signed and used FDA 1572 for clinical trials after 30.06.2025. will be considered a finding (FDA 1572 dated after 30.06.2025.)
  • From 30.06.2025., the change applies to both new studies and existing ones where updates to previously signed FDA 1572 are necessary