Drug Evaluation Committee 2008-40 Example of "any change that may affect the clinical trial or increase the risk to subjects
Related classification: Other
Date of first publication: Mar. 2009
Question
GCP Article 46 "Deviation from the study protocol" states that only emergency deviations shall be reported immediately to the head of the implementing medical institution by preparing a document stating the reason. What kind of cases do you think this refers to?
For example, does it include deviations such as when a physician fails to comply with the protocol and administers the investigational drug to a subject with symptoms by mistake, even though the protocol stipulates that the drug should not be administered to subjects with the symptoms specified in the exclusion criteria of the protocol? In such a case, would it be acceptable for the investigator to prepare a report as in the past and report to the head of the medical institution and the sponsor regarding the content, circumstances and response, and for the head of the medical institution to request that the report be submitted to the IRB?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 46 Guidance 6 states that "The investigator shall promptly submit a report to the sponsor, the head of the site, and the investigational review board, etc. via the head of the site on any changes in the clinical trial that may have a significant impact on the conduct of the clinical trial or increase the risk to the subjects. The term "significant impact" is considered to include changes that affect the scientific evaluation of the clinical trial. Also, "a change that increases the risk to subjects" is considered to be a change that is clearly likely to have a significant impact on the safety of the subjects.
Specific examples of such changes and whether or not individual changes fall under the above-mentioned changes depend on the characteristics of the investigational drug and the purpose of the study.