Drug Evaluation Committee 2015-36 Version Control of Explanatory and Consent Documents
Related classification: Obtaining consent
Date of first publication: February 2016
Question
Protocol numbers were omitted from the explanation and consent documents. It was pointed out by the monitors that they could not guarantee that the stored consent documents were for the relevant clinical trial. By the time both parties realized this, the subject had already been enrolled.
Our response was to leave a letter from the investigator stating that "Although the protocol number was omitted, we confirmed that it was the consent document for the relevant clinical trial" for the consent document for the subject who had already consented and completed the clinical trial, and to ask the investigator to arrange to have the protocol number written in the document as soon as possible in the future. We are considering this.
If so, will the date of creation or number of versions of the explanatory and consent documents be changed? If so, is it acceptable to only report the changes at the Clinical Trial Review Committee? (We do not think the change will affect the continuation of the clinical trial.)
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 51 of the GCP stipulates the items to be included in the explanatory document, but the protocol number is not mandatory. However, it is necessary that it is clear which subject obtained consent for which clinical trial and at which point in time the explanatory document was used. For this purpose, it is necessary to link the explanation document and the consent document, and we believe that one of the ways to do so is to include the protocol number and version number. Please note that it is desirable to combine the explanatory document and the consent document into one document or a single document (GCP Article 51, Paragraph 1, Guidance 6). In this case, it is important to maintain a record of the process of obtaining consent so that it can be verified at a later date, although it is understood that a separate record will be created for subjects who have already completed the clinical trial.
In addition, you are going to make a change to add a protocol number, and I think it is necessary to revise the creation date and version number to distinguish it from the previous version and to make it identifiable. In such cases, the head of the site must submit the revised documents to the Investigational Review Committee because the documents subject to review by the committee must be kept up to date (see GCP Article 31, Paragraph 2, Guidance 3, Note 1).
On the other hand, GCP does not indicate a "report" to the Clinical Trial Review Committee, and the necessity of review (meeting review or expedited review) depends on the judgment of the head of the site and the procedures of the Clinical Trial Review Committee (see past opinions: 2009-12, 2009-27, 2010-12, and 2012-11).