Drug Evaluation Committee 2010-24 Confirmation of Intention to Continue a Clinical Trial with Revision of Explanatory Documents (Part 2)
Related classification: Obtaining consent
First published: August 2010
Question
Recently, the selection/exclusion criteria for a clinical trial were changed. In accordance with this change, it was decided to delete some of the selection criteria in the consent document, but the sponsor is of the opinion that "the change is not a safety-related change and does not fall under Article 54 of the GCP, so subjects who have already entered the trial do not need to give their consent again". In my past experience and training, we were supposed to obtain re-consent when the consent document was revised, regardless of the content, so please tell me if this view is acceptable under GCP.
In the first place, was it necessary to revise the consent document if the change was to the extent that re-consent was not required? Is it not sufficient to explain the changes orally to the subjects and obtain their consent? Please also tell us about this.
Also, when would the oral explanation be required to obtain a new consent? Although it is stated that it should be done "promptly," where is the actual starting point desirable?
- A)Date when the information was provided by the sponsor (date of implementation of the explanation of the revision of the clinical trial protocol)
- B）Date of agreement
- C）Date of provision of the sponsor's draft of the revised consent document
- D)Date of preparation of revised consent document by investigator
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in Article 54 of the GCP, when information is obtained that is deemed to influence the subject's decision as to whether or not to continue participating in a clinical trial, the investigator must immediately provide the subject with said information, record this in writing, and confirm whether or not the subject will continue to participate in the clinical trial. The investigator must confirm whether or not the subject will continue to participate in the clinical trial. This must be done from the time the investigator determines that the information obtained "influences the subject's decision. Furthermore, as stipulated in Paragraph 2 of the same article, the investigator is required to consider the necessity of revising the explanatory document based on this information, and if he/she determines that such revision is necessary, he/she is required to promptly revise the explanatory document.
On the other hand, if the "change in the description of selection/exclusion criteria in the explanatory document" in your question is not a change that would affect the subject's decision to continue participating in the clinical trial, then it is not a revision based on Article 54 of the GCP, but rather a revision to update the explanatory document based on the latest clinical trial protocol (method of the clinical trial). If the change is not based on GCP Article 54 and does not affect the subject's willingness to continue participating in the clinical trial, it is not considered a revision based on GCP Article 54. We believe that it is up to the investigator to decide whether or not the subject's re-consent is required for such a change.
In addition, obtaining the consent of new subjects (new entry after changing the selection/exclusion criteria) must be done using the revised explanatory document after the changes to the protocol and explanatory document have been approved by the investigational review committee and the instructions and decision document by the head of the site have been issued.