Drug Evaluation Committee 2018-12 Positioning of Addendum to the Clinical Trial Protocol
Related classification: Other
Date first published: August 2018
Question
The Global Clinical Trial has now added audio recording to the clinical trial procedures. Subject consent is required for audio recording, and if the subject does not consent, the subject will not be allowed to participate in the clinical trial.
Global has not revised the study protocol because local regulations allow for the audio recording to be included in the explanatory document and the study to proceed even if it is not included in the study protocol. However, in Japan, GCP does not allow the inclusion of information in the explanatory document that is not included in the protocol, so an addendum to the protocol is prepared and the explanatory document is revised.
The Clinical Trial Review Committee, which received the above information from the sponsor and requested a review of the addendum to the protocol and the revised explanatory document, pointed out that it is strange to revise the explanatory document when there is no revision of the protocol.
My question is, if the main body of the protocol is not revised and an addendum is created, is there any problem with the Trial Review Committee treating this addendum the same as the main body of the protocol for review, although it has contents that affect consent? Or, if the contents of the addendum affect consent, is it necessary to revise the main body of the protocol to review the addendum? We would appreciate it if you could tell us how you handled similar cases and how you will handle them in the future.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Basically, there is no problem if items that should be described in the protocol are described in other documents such as addendums. Therefore, there is no problem in treating addenda and other documents in the same manner as the main body of the protocol and reviewing them by the Clinical Trial Review Committee.
However, when the sponsor revises the protocol, it is necessary to agree in writing with the investigator on the contents of the revision, regardless of the form of revision, except when the contents are only administrative changes to the clinical trial (GCP Article 7, Paragraph 4/5, Guidance 5; Article 46, Guidance 1).
Although we do not know how the "voice recording" in your question will affect the conduct of the clinical trial and subjects, we believe it is necessary to consider the importance of the change and determine whether it is appropriate to include it in an addendum or other document.
Since each sponsor has a different view on whether to treat addenda and other documents as equivalent to the main body of the protocol, we recommend that you consult with the sponsor before deciding whether to treat addenda and other documents as equivalent to the main body of the protocol.