Good Clinical Practice: A Question & Answer Reference Guide - May 2016 - 114

GCP: A Question & Answer Reference Guide
3.34 Q. In the upper right hand corner of the 1572, an US Office of Management and Budget (OMB) expiration
date is provided. Once a 1572 is completed and signed, does the form expire at any point?
A. Once a clinical investigator signs a 1572 and provides the completed and signed form to the sponsor, the form
does not expire in the sense that it must be renewed at some specific point in the future. Some are confused by
the "Expiration Date" that appears within the box in the upper right hand corner of the 1572's first page. This is a
date that is relevant only to US government offices and agencies-specifically, the US Office of Management and
Budget (OMB) and the FDA. This refers to FDA's internal requirements under the Paperwork Reduction Act and
the collection of information (see bottom of page 2 of form) by a government agency, in this case FDA.
"There is no need to prepare and sign a new 1572 when the OMB expiration date has been reached," the FDA
states in its May 2010 guidance/information sheet titled, "Frequently Asked Questions-Statement of Investigator
(Form FDA 1572)."
At the same time, clinical investigators and sponsors should check to make sure that the version of the form that
they are completing/collecting is the version that is in effect at that time. In some cases, the expiration date on the
form will have passed even though that version of the form remains in effect. In addition to the OMB expiration
date, the bottom left of the form contains the date of the latest version of the form. The current form for example,
shows a version date of 7/13 with an OMB expiration of April 2015.
3.35 Q. Should we always use the most current, non-expired OMB version when we are initially completing
Form 1572? Some sponsors prefer to use a version that is expired in order to be consistent across the
study. Since it is the investigator's responsibility for the accuracy of this form and the information
contained therein, as a site should we insist to use the most current version?
A. In numerous informal opinions on the completion of the Form FDA 1572, FDA has stated that it is preferred
that you use the most recent version. However, it is not against FDA regulations if you use an expired form.
Remember, the form date reflects OMB (Office of Management and Budget) approval of the form as an FDA form
that meets the requirements of the Paperwork Reduction Act. FDA is required to submit a request for renewal of
all forms no later than the expiration date on the most current form. However, the review and re-approval process
and the issuance and posting of a new form can often be delayed. The existing form can be used as intended in
the interim, despite the fact that it bears an expired date, and there is no need to update the form after one with an
updated expiration date is issued. Since the form typically does not include changes or modifications to the content,
using an older version of the form, as long as it is completed before the investigator's participation in the study, is
acceptable.
3.36 Q. Is it true, as some claim, that the 1572 must be double-sided and not printed on two pages? Is this an
FDA requirement or policy?
A. Either a double-sided 1572 or a version of the form printed as a two-page document is acceptable, the FDA notes
in its May 2010 guidance/information sheet titled, "Frequently Asked Questions-Statement of Investigator (Form
FDA 1572)." "However, FDA recommends that a two-page document be stapled so that there is no question about
what form the investigator signed," the agency notes in the guidance.
3.37 Q. Suppose that a subject lives a great distance from a study site, and because of that, the subject's local
physician will administer the weekly blood test required by the protocol (i.e., rather than requiring the
subject to travel to the study site weekly). In this case, would that local physician be considered a subinvestigator and, if so, be listed on the Form FDA-1572?
A. In an informal response to this question, the FDA stated, "When a subject lives a long distance from the clinical
trial site, it may not be convenient or practical for the subject to return to the site to perform routine follow-up
procedures (e.g., blood or other lab test, routine eye exam). To reduce the inconvenience for study subjects, the
study protocol may allow a subject's personal physician to perform a specific test or activity. In such cases, FDA
does not view the personal physician as a sub-investigator, and does not expect him/her to be listed on a 1572.
Instead, study records should describe the types of tests/activities that may be performed by the subject's personal
physicians and note that the results will be provided to the clinical investigator. Each subject's case history should
also indicate the contact information for the person who performed the test/activity and the results."
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