The FDA’s revised information sheet on clinical investigator inspections includes a new section on international inspections.

The guidance noted that “although sponsors of clinical trials conducted outside the U.S. are not required to file an [investigational new drug (IND) application], sponsors submitting foreign clinical studies not conducted under an IND to FDA must comply with requirements in 21 C.F.R. §312.120 [and] when FDA considers whether to accept non-U.S., non-IND clinical studies in support of an IND, [new drug application or biologics license application] an FDA inspection may help in determining whether the study was conducted in accordance with 21 C.F.R. §312.120.” Specifically, the inspection will evaluate whether the following criteria are met:

• The study is well-designed and well-conducted.
• The study is conducted in accordance with good clinical practice (GCP), which is defined as a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials in a way that provides assurance that the data and reported results are credible and accurate and that the rights, safety, and well-being of trial subjects are protected.
• The study has been reviewed and approved (or provision of a favorable opinion) by an independent ethics committee (IEC) prior to study initiation, continuing review of an ongoing study by an IEC, and the freely given and documented informed consent of the subject (or the subject’s legally authorized representative if the subject is unable to provide consent) prior to any study-specific procedures.

For device studies, the guidance said an inspection will evaluate whether:

• The data is valid; and
• The studies are conducted in conformance with the "Declaration of Helsinki," or the laws and regulations of the country in which the research is conducted, whichever affords greater protection to the human subjects.
   

The guidance also adds additional information on the Notice of Initiation of Disqualification Proceedings and Opportunity to Explan (NIDPOE) process.

For more on the revised information sheet will be in the September Guide to Good Clinical Practice.