#14 Practical RWE – Documentation: 1572s

#14 Practical RWE – Documentation: 1572s


It’s a question that still (frustratingly) comes up in the context of non-interventional studies conducted in Europe…”Do I need a signed 1572 from my investigators?”

Form FDA 1572, also known as the “Statement of Investigator,” is a document that is specifically used in the context of clinical trials conducted under the regulations of the United States Food and Drug Administration (FDA). This form is a contract between the principal investigator and the FDA, indicating the investigator’s commitment to conduct the trial in accordance with FDA regulations.

FDA 1572 forms (1572s) are not applicable to clinical trials or non-interventional studies conducted in Europe.

In 2019, the Spanish Competent Authority (AEMPS) joined the position of other European Agencies (Denmark, Germany, Norway, Sweden and Switzerland) by releasing a statement, announcing that the FDA 1572 forms should not be signed by Spanish investigators. The main reason being that 21 CFR 312 is not the regulation in force in EU/Spain:

“The investigators in Spain cannot commit to comply with the established requirements by FDA 1572 form. A clinical trial carried out in Spain, the rest of EU, and EEE must not follow any third-country’s legislation. The clinical trial must be carried out in accordance with Spanish legislation that transposes EU directives 2001/20/EC, 2001/83/EC and 2005/28/EC, and EU regulation no. 536/2014 (once this will be in force)… It should be noted that The inspectors of clinical trials in Spain will consider the signature of FDA 1572 form as a serious finding applicable to the Sponsor of the clinical trial and to the Principal Investigator too as s/he will be the signatories of this form.”

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

European clinical trials are governed by different regulations and guidelines to those in the USA, primarily the EU Clinical Trials Regulation (EU) No 536/2014, and the ICH Good Clinical Practice (GCP) guidelines.

For non-interventional studies in Europe, the relevant local and EU regulations and guidelines apply, and the FDA 1572 form is NOT relevant or required.

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