Drug Evaluation Committee 2017-35 Separate pages of the revised points of the explanatory documents for subjects
Related classification: Obtaining consent
Date first published: December 2017
Question
In relation to GCP Article 54, Paragraph 2, we provided the investigator with new information that may influence the subject's decision, and received a request to "prepare a separate volume (including the consent document) that summarizes only the changes in the revised explanatory document, and explain only that separate volume to the subjects participating in the trial and obtain their written consent". The physician requested that the company "prepare a separate volume of the revised explanatory document that summarizes only the changes (including the consent document), explain the changes to subjects participating in the clinical trial using only the separate volume, and obtain written consent. Please explain the appropriateness of this under GCP.
Background/Reason
- In some cases, we have had to revise an explanatory document that exceeds 20 pages with only a few changes, making it difficult for subjects to understand the revised sections.
- Since the inclusion period of this clinical trial has ended and no new subjects will participate, we would like to provide an explanatory document and consent form that contains only the new information to be communicated, taking into consideration subjects who are still participating.
In this case, the latest version of the instruction document consists of two parts: the main body (the instruction document before the revision) and a separate volume. Since the main body of the document meets the requirements of GCP Article 51 and written consent has already been obtained, we believe that there is no problem in using only the separate volume when explaining new information. From the viewpoint of "free will" as stipulated in Article 54, Paragraph 3 of GCP, we plan to include the contents regarding free will that fall under Article 51, Paragraph 1, Items 8 and 9 of GCP in the separate volume.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Since all items stipulated in Article 51 of GCP must be included in the explanatory document to subjects, we believe that, in principle, the explanatory document should be a single document.
However, for unavoidable reasons, such as a large volume of information, it may be acceptable to use a separate volume for some of the items. However, even in this case, since the main body and the separate volume are one and the same explanatory document, it is necessary to clearly state this in the main body or the separate volume of the explanatory document. Also, when recording the subject's intention to continue participation in the trial in the consent form, it must be clear that the subject consented to both the main body and the separate volume of the explanatory document.
In any case, if you choose to use this form for the explanatory document, we would appreciate your judgment from the standpoint of the subject as to what method of explanation is best for the subject, and what structure is easiest for the subject to read and understand as the explanatory document in his or her hand.