1572 in International Setting

There has been ample discussion on the FDA1572 and its use in international research. The FDA has provided some useful guidance this year. Some highlights from that today.

Local Law vs CFR
If a foreign clinical study is being conducted under an IND, investigators are responsible for complying with the applicable laws and regulations of the country in which the study is being conducted, regardless of whether the study is being conducted under an IND. The FDA recommends that sponsors obtain signed, written statements from investigators acknowledging their commitment to comply with local laws and requirements. In addition, if a foreign clinical study is being conducted under an IND, the investigator must sign Form FDA 1572 (investigator statement) and ensure that the study is conducted in accordance with the investigator statement and all other applicable regulations under 21 CFR Part 312.

Signing of the 1572 by a foreign investigator in a study under IND
We know that a foreign investigators cannot commit to all of the requirements on the form, specifically IRB membership (21 CFR 56.107). IRB review and approval is required before a clinical study can be initiated under an IND (21 CFR 56.103(a)).

FDA may waive any of the IRB requirements but only when alternative mechanisms for ensuring protection of the rights and welfare of human subjects are acceptable. In this case, typically an Independent Ethics Committee (IEC) that operates in accordance with Good Clinical Practice (GCP) is utilized instead of a U.S. IRB. Although its membership and functions for assuring human subject protection are comparable to an IRB, an IEC may not meet all of the IRB requirements contained in 21 CFR Part 56.

The sponsor should submit a waiver request to the IND under which the study will be conducted. The sponsor will be informed by the agency in writing whether the waiver request is denied or granted.

IMPORTANT: If a waiver is granted, the sponsor should have investigators attach a copy of the letter granting the waiver to the signed 1572 in the investigator’s record.wow gold

FDA 1572's continued use, though expired

The FDA 1572 form has an official Expiration Date: May 31, 2009. Almost 6 months ago!

However the FDA is reporting on their website that "FDA has OMB approval to use the form until 8/31/2011".

This means that the form will not be updated, it will continue to be used in it's current form, sporting the current expired expiration date, until end of summer 2011.

Though being an FDA, therefore US form, this form is widely used outside of the US, even though, by signing it, non-US investigators are agreeing to work in accordance with the US Code of Federal Regulations (specifically 21 CFR parts 50, 56, 312.62, 312.64, 312.68 and 312 as a whole).

REMINDER:
At audits and inspections, by the way, still often a 2 page version of the 1572 is found, with an original signature. This form needs to be double sided, signature on the back, not enabling changes to the details on the front without having to sign again. In May 2010, the FDA stated that either a double sided 1572 or a two-page document "is acceptable; however, FDA recommends that a two-page document be stapled so that there is no question about what form the investigator signed."
 Any updates warrant a new FDA 1572 to be created, and newly signed and dated.wow gold