• By ICR Secretariat
  • Posted Wednesday, June 26, 2019

Use of FDA 1572 Forms in Spain

https://www.chcuk.co.uk/aemps-statement-regarding-use-of-fda-1572-forms/

The Spanish Competent Authority (AEMPS) has joined the position of the other European Agencies (Denmark, Germany, Norway, Sweden and Switzerland) by releasing a statement on the 24th April 2019, announcing that the FDA1572 forms should not be signed by Spanish investigators.

Main reason is that 21 CFR 312 is not the regulation in force in EU/Spain and that signing off the FDA1572 by a Spanish investigator requires the Ethics Committees in Spain to adhere to 21 CFR 312.