Working with FDA - Form FDA 1572 (Statement of Investigator) Signature Waivers at Non-US Sites

Description: FDA regulations allow for waivers of certain IND requirements when the proposed alternative course of action satisfies the purpose of the requirement. Both the FDA and EU have adopted ICH, including the Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Leveraging guidelines outlined in ICH E6, FDA established a Form FDA 1572 signature waiver process for those investigators conducting studies at non-US sites who are unable to sign the form. To obtain a 1572 signature waiver, FDA requests:
• A completed but unsigned 1572
• General information about the IND
• Study site and the reason the investigator won’t sign 1572
• The Sponsor’s proposed alternative course of action to satisfy the purpose of the requirement of a signed Form FDA 1572. An example of such a course of action could include:
o An explanation of how the sponsor will ensure investigator compliance with Good Clinical Practice (GCP) requirements for the purposes of FDA requirements
o Sponsor’s declaration that it has secured the investigator’s commitment to comply with ICH E6

Between 30 August 2018 and 5 September 2019, FDA received 65 inquiries and requests for 1572 signature waiver, of which 42 were complete. Requests for 1572 signature waiver were received by both the Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Of the 42 complete requests, 40 were granted a waiver. Reasons for not granting a waiver included: (1) no 1572 was required for the study, and (2) 1572 signature waiver could not be granted retroactively. Countries with investigators receiving a waiver included Austria, Belgium, Canada, Denmark, Finland, France, Germany, Italy, The Netherlands, Spain, and United Kingdom.

The outcome of discussions and the waiver procedure were presented to FDA and European inspectors.