Use of the FDA 1572 form for clinical trials in Europe

11 Jan Use of the FDA 1572 form for clinical trials in Europe

The Danish Medicines Agency (DMA) has published an article about whether or not FDA 1572 form should be signed by the investigators outside US in a multinational trial.

According to DMA, an investigator in Denmark cannot comply with the requirements in the 1572 form, therefore the investigator should not sign 1572 form. A clinical trial conducted at a site in the EU and European Economic Area (EEA) cannot be conducted under any foreign country legislation. The trial must be conducted in accordance with the national legislation that is set forth in the Directives 2001/20/EC, 2001/83/EC, and 2005/28/EC (and the Regulation (EU) No 536/2014 when in force).

When conducting a multinational trial in US and outside US, the sponsor can submit one protocol to the FDA that clearly defines and describes IND sites (sites in US) and non-IND sites (sites outside US). The investigators at these non-IND sites do not have to sign the Form FDA 1572. However, the sponsor must ensure that the non-IND sites complies with 21 CFR 312.120, “Foreign clinical studies not conducted under an IND.”, which requires that the trial is conducted in accordance with Good Clinical Practice (GCP) and that FDA is able to validate the data from the trial through an onsite inspection if the FDA deems it necessary.

References:

https://laegemiddelstyrelsen.dk/en/licensing/clinical-trials/gcp-inspection/clinical-trials-under-us-legislation/