Drug Evaluation Committee 2017-56 Selection of Studies for Audit
Related classification: Other
Date first published: December 2017
Question
Along with a double-blind comparative study of a certain study drug, we are planning a long-term safety confirmation study (a study to provide an investigational drug to subjects until its approval) in which subjects who have completed the relevant clinical trial will be transferred. Is it possible that you will not conduct an audit for such a long-term safety confirmation study, since the GCP stipulates the following? If not, is the reason because the long-term safety confirmation study will not be used as data for regulatory submission?
GCP Article 23, Paragraph 1, Guidance 4
Audits of individual clinical trials are conducted after determining the scope and timing of audits of the sponsor, site, and other facilities involved in the conduct of the clinical trial, taking into consideration the importance of the trial to the regulatory authorities, the number of subjects, the type of trial, the level of risk of the trial to the subjects, and any problems found in monitoring, etc. The audit should be conducted in accordance with the following criteria. (2) The audit shall be conducted after determining the subject of the audit and its timing, etc.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The purpose of Guidance 4, Paragraph 1, Article 23 of GCP explains that for each individual clinical trial to be conducted, an audit shall be planned in advance focusing on risks and audits shall be conducted accordingly in order to ensure the protection of subjects and the reliability of trial data.
In the audit plan, the target and timing of the audit are decided in consideration of the system of the clinical trial and the degree of risk in each clinical trial, so it is possible that some clinical trials may not be audited depending on the plan of the audit department.