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
The audit of each clinical trial shall be conducted after determining the scope and timing of the audit of the sponsor, Investigator Site, and other sites involved in the conduct of the clinical trial, taking into consideration the importance of the clinical trial to the regulatory authorities, the number of subjects, the type of clinical trial, the level of risk of the trial to the subjects, and any problems found in the monitoring, etc. The audit of the clinical trial shall be conducted after determining the scope and timing of the audit of the clinical trial. (2) The audit shall be conducted after determining the subject and timing, etc. of the audit of the sponsor, the site and other facilities involved in the clinical trial, taking into consideration the type of subject, the level of risk to the subject and any problems found in monitoring, etc.
JPMA's Opinion
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.