Drug Evaluation Committee Version Control for the 2015-36 Informed Consent Document and Explanatory Document
Related Category: Obtaining Informed Consent
Initial Publication Date: February 2016
Question
The protocol number was omitted from the package insert and informed consent form. A monitor pointed out that there was no guarantee that the stored informed consent forms belonged to the relevant clinical trial. By the time both parties noticed this, subjects had already been enrolled.
Our proposed response is to have the principal investigator prepare a written statement regarding the informed consent forms for subjects who have already provided consent or for whom the trial has been completed, stating, “Although the protocol number was omitted, we have confirmed that these are the informed consent forms for the relevant clinical trial.” We plan to request that forms with the protocol number included be arranged as soon as possible going forward.
In that case, will the dates of creation or version numbers for the informed consent form and the study brochure change? If they do change, would a simple report to the Institutional Review Board (IRB) suffice? (We do not believe this issue will affect the continuation of the clinical trial.)
JPMA's view
The items to be included in the informed consent form are specified in GCP Article 51; however, the inclusion of the protocol number is not mandatory.However, it is necessary to clearly identify which clinical trial the subject participated in and which version of the informed consent document was used to obtain consent at a given point in time. To achieve this, it is necessary to link the informed consent document to the consent form; we believe that including the protocol number and version number is one way to do so.Please note that it is considered desirable for the informed consent document and the consent form to be integrated into a single document or a set of documents (GCP Article 51, Paragraph 1, Guidance 6). In this case, while you mentioned that separate records will be created for subjects who have already completed the clinical trial, it is important to maintain records that allow for the verification of the consent process at a later date.
Furthermore, while you plan to make changes by adding the protocol number, I believe it is necessary to revise the creation date or version number to distinguish these records from previous versions and ensure they can be identified.In such cases, since the Chairperson of the Investigator Site must ensure that the document subject to review by the Institutional Review Board (IRB) is the most current version, the revised document must be submitted to the IRB (see GCP Article 31, Paragraph 2, Guidance 3, Note 1).
On the other hand, GCP does not specify a requirement to “report” to the Institutional Review Board (IRB); whether review (either through a meeting or expedited review) is necessary is determined by the judgment of the Chairperson of the Investigator Site and the procedures of the IRB (see past opinions: 2009-12,2009-27, 2010-12, and 2012-11).