Drug Evaluation Committee 2014-48 Anonymization of Subjects' Names in Materials Provided to Clinical Trial Sponsors
Related classification: Other
First published: Apr 2015
Revised publication date: Mar 2021
Question
We are currently preparing for a global study, and the procedure is to send MRI, ECG and other information to the sponsor, including the subject's date of birth, initials and gender. . shall be protected with due regard for the privacy and confidentiality of the subject." In general, without considering GCP, etc., if we know the date of birth, initials, and gender, it seems that the subject can be identified to some extent. Is this acceptable?
Some sponsors only use the date of birth as a record that may reveal the subject's identity as mentioned above, so we consulted with you because we were unsure of the best way to make a decision.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 1 Guidance 2 (11) of the GCP states that "Records that may reveal the identity of the subject shall be protected with due consideration for the preservation of the subject's privacy and confidentiality. However, there are no specific provisions regarding the contents of such records. It would be difficult to reveal the identity of a subject based solely on "date of birth, initials, and gender," but additional information or a combination of these would increase the likelihood of identifying the subject. From this perspective, it is desirable not to collect data that are not necessary to evaluate the efficacy and safety of a clinical trial.
In addition, GCP Article 2 Guidance 18 (8) states that "subject identification code" is a unique identification number assigned to each subject by the investigator to protect confidentiality regarding the identity of each subject, and is used in place of the subject's name, identifiable number and address when the investigator reports adverse events and other trial-related data. The number is to be used in place of the subject's name, identifiable number, address, etc., when the investigator reports adverse events and other trial-related data. The GCP Article 26, Article 26, Section 1 of the GCP states "The name, number and address of the subject shall be used instead of the name, number and address of the subject to identify the subject when the investigator reports adverse events and other trial-related data. Furthermore, GCP Article 26.1 Guidance 5 states, "The sponsor shall use a clear subject identification code that enables identification of all data reported for each subject. Therefore, if "date of birth, initials, and gender" are collected for the reason of subject identification, it would be desirable not to collect these and to identify subjects only by subject identification code.
Reason for revision of opinion
With the issuance of the GCP Guidance (No. 0831-15 issued on August 31, 2020 by the Pharmaceutical Affairs Agency of Japan), minor changes have been made to the descriptions.