Question: Do researchers involved in conducting clinical trials in the Republic of Slovenia have to sign FDA Form 1572 at the request of the sponsor?

Answer: No.

Rationale: Researchers signing FDA Form 1572 confirm that they will conduct a clinical trial of a drug in accordance with United States of America (IND) Investigational New Drug Regulations . However, clinical testing at the site of the trial in the Republic of Slovenia cannot be carried out in accordance with any legislation of a foreign country, since the national legislation laid down in Directives 2001/20 / EC, 2001/83 / EC and 2005/28 / EC must be observed. (or in EU Regulation No 536/2014 when it will become applicable).

Clinical trials submitted to the US Food and Drug Administration (FDA), however, must comply with US law (see: Title 21 Code of Federal Regulations (CFR) Part 312 ). When submitting an application to the FDA, the sponsor may use a number of different options to ensure compliance with these requirements, while not requiring researchers outside the US to sign an FDA Form 1572 (see: FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND Frequently Asked Questions (March 2012) in Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs Frequently Asked Questions – Statement of Investigator (From FDA 1572) (May 2010 ).

JAZMP informs researchers in the Republic of Slovenia that pharmaceutical inspectors will in future consider good clinical practice inspections at the trial site the signing of FDA Form 1572 by participants in the conduct of the clinical trial as a drawback.