Drug Evaluation Committee 2012-43 Retention of Signed Consent and Explanatory Documents
Related classification: Obtaining consent
Date of first publication: Feb. 2013
Question
The sponsor A, who is conducting a global clinical trial, has informed us that the Japanese way of handling the consent document and explanation document, "The original explanation document and a copy of the consent document are provided to the subject and only the original consent document is kept at the facility," is not in accordance with ICH-GCP procedures and may be pointed out during an inspection by the FDA in the U.S. Therefore, we have decided to use the conventional way of storing the consent document and explanation document. Therefore, we were requested to change the existing method of storing documents at the time of obtaining consent.
According to 4.8.11 of ICH-GCP, a copy of the consent document and the informed consent form should be provided to the subject, and the original should be kept by the investigator. The "informed consent form" here is interpreted as a combination of the "explanation document" and the "consent document" rather than the "consent document" in the Japanese GCP, according to the explanation in ICH-GCP 1.28. (The ICH-GCP does not separate the "explanation document" and the "consent document" as in the Japanese GCP. (ICH-GCP does not separate "explanation document" and "consent document" as in the Japanese GCP, but uses "informed consent form" which includes both).
The protocol also states that "a copy of the dated and signed informed consent form should be given to the subject," and the original should be kept at the site. However, it is impractical to make a full-page photocopy of the informed consent form, so the actual procedure is to prepare two copies of the informed consent form, store the original combined informed consent form and informed consent form at the medical institution, and give the subject a copy of the informed consent form (one of the two copies) and the informed consent form.
At sponsor B of another international clinical trial, the study protocol states that "the original of the dated and signed consent and explanation document will be kept by the investigator and a copy will be given to the subject," but we inquired about this as it is the conventional Japanese handling (only the original consent document remains at the medical institution). However, when I inquired about this, the medical institution responded that there is no problem because the consent document contains the IRB-approved version number of the explanatory document, and if we keep one bound version (booklet) of the document, we can explain to the subject that we explained and provided the subject with the appropriate explanatory document.
When we asked Company A how other countries (e.g., the U.S.) handle this issue, they replied that they have two documents, like a contract, in which the consent document and the explanation document are combined into one document, signed by both parties, and one copy of each document is kept. (In the U.S., "duplicate documents" are not accepted.) Isn't this also not strictly following the "ICH-GCP procedure"? There is no evidence that what both parties are keeping is identical, since it is not a copy.
In both cases, Company A (with two copies of the explanatory document) and Company B (the original of the explanatory document is given to the subject, but the number of versions can be proved by the number of versions on the consent document), it cannot be said that the explanatory document given to the subject and the explanatory document stored at the medical institution are absolutely identical, but in that case, Company B's response would be acceptable, wouldn't it? According to Company A, it was not actually pointed out to them, but they want to take measures in advance because they have this kind of concern within the company. Company A says that as long as the originals remain at the medical institution, there will be no investigation of the data stored by the subjects, and therefore, it is not important. It is as if they are saying that as long as the original remains at the medical institution, it is unimportant.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in your question, under the Japanese GCP (GCP Ministerial Ordinance), the explanatory document and the consent document should be an integrated document or a set of documents (GCP Article 51, Paragraph 1, Guidance 6), and both of these documents are subject to retention (GCP Article 41, Paragraph 2), so the regulatory requirements The regulatory requirements are equivalent to those of ICH-GCP. However, there are some differences between countries and regions in the actual storage of the explanatory document and the consent document ("informed consent form" in ICH-GCP). In Europe and the U.S., the explanatory document and the signed consent form are often stored together, while in Japan, the signed consent form is generally stored separately from the explanatory document. We believe that this is important.
In addition to storing the original explanatory document and signed consent document as a single unit, the explanatory document used to obtain consent and provided to subjects (including version information) should be clearly stated in the consent document, and a set of sample explanatory documents and consent documents approved by the investigational review committee, as well as the original signed consent document, should be stored, We believe that all of these storage formats satisfy the requirements of not only the GCP Ministerial Ordinance but also ICH-GCP.
If there is a provision in the protocol, as in this case, we recommend that you comply with the provision. If there is no provision, we recommend that you consult with the sponsor before taking action.