6/08/2021
The US Food and Drug Administration (FDA) issued a draft information sheet guidance “Frequently Asked Questions Statement of Investigator (Form FDA 1572)” as an update to the same titled guidance document from 2010. It provides clarification on when a waiver can be requested when an investigator outside the US cannot or will not sign a Form 1572. The purpose of the Form FDA 1572 is to collect applicable information from the investigators and sub-investigators at clinical research sites to verify they have the appropriate experience and background to conduct the clinical trial. Signing the 1572 is an agreement to conduct the clinical trial according to the applicable FDA regulations while protecting the safety and rights of the study participants and the quality of the data.
Some national, regional, or local laws may prohibit an investigator from signing the Form FDA 1572. The guidance clarifies that if the investigation is not under an Investigational New Drug Application (IND), there is no need for the 1572. It is recommended that a signed statement be obtained from the investigators stating that they will comply with national, regional, or local regulations. If the study is under an IND, investigator must still follow all applicable regulations and must sign the 1572 unless the sponsor requests and receives a waiver under the exceptions stated in 21 CFR 312.10. A granted waiver would allow an IND study to be conducted without a signed 1572. It is important for the sponsor to clearly define an alternative course of action that ensures the investigator complies with the same commitments as is in the 1572. The investigator would then need to comply with the terms of the waiver commitment. The draft guidance outlines details of how to file a waiver and some examples of commitment statements.
Do you work with investigators outside the US where this has been a concern? What are your thoughts on the draft information sheet guidance? Submit your comment on the draft guidance HERE through July 19, 2021.
Site investigators need to complete GCP training within three years of the start of a new study. Need GCP training for investigators or clinical research sites? Clinical Pathways offers a comprehensive, interactive eLearning course that meets the minimum criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors. To sample our interactive training or to purchase, please visit our store HERE.
-The Clinical Pathways Team
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