Tuesday, 10 November 2009

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

3 comments:

  1. Sherry Armstrong-Wilkinson11 November 2009 at 13:35

    An interesting comment was made just this week by a Sponsor conducting a study under an IND....they felt that Investigators outside the US did not need CFR training! I wold be interested in your thoughts....

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  2. Interesting indeed...

    I think it is already the case in the majority of cases, that investigators do not get CFR training.

    There is certainly a case to be made that investigators ex-US do not have to work according to the CFR. They should work according to the local law of the country in which they are practicing Clinical Research. An argument I tend to support.

    This goes directly into the discussion surrounding the use of the 1572 outside of the US. The form is mainly used to gather information about the site, to submit to the FDA for trials run under an IND. This is often also how the form is explained to the investigators.

    The intended use of the form, however, is more than that. From the FDA guidance document: "The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the investigator to provide certain information to the sponsor and assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic."

    That assurance to comply with FDA regulations is often overlooked.

    My personal opinion is that the 1572 should not be used outside of the US. An alternative form to collect the investigator information, without the statement of the investigator, is more suitable. Alternatively, we should explain the use of this form much better to the investigators and give them the choice to sign or not, rather than having them sign a document, not truly understanding what they're stating by signing it.

    I've heard there are companies already which have stopped collecting 1572s outside the US. Also the FDA seems not opposed to an alternative way of collecting investigator information.

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  3. This goes directly into the discussion surrounding the use of the 1572 outside of the US. The form is mainly used to gather information about the site, to submit to the FDA for trials run under an IND. This is often also how the form is explained to the investigators.

    http://www.studyscavenger.com

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