Drug Evaluation Committee 2007-21 Use of Consent Documents Prepared by Medical Institutions
Related classification: Obtaining consent
Date of first publication: Jan. 2008
Question
I know it is customary for the sponsor to prepare the consent form in advance, but if the frequency of use is unexpectedly fast and additional copies cannot be delivered to the site in time, is it possible to have the site sign the consent form they have prepared and make a copy of that consent form to be used as a copy?
I know this should not be done, but I would appreciate your opinion.
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As of December 2023
Consent document prepared by the sponsor
Generally, the sponsor prepares a booklet-type consent/explanation document that consists of two or three copies of the consent form and an explanation document.
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As of December 2023
Consent/explanatory document prepared by the site
The documents are printed at the facility, and one copy of the consent form is signed by the patient, and the necessary number of copies are made as a copy. The format and content of the documents are the same for both the sponsor and the facility.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 51, Paragraph 1 of the GCP states that "the investigator shall deliver an explanation document (omitted)" when providing an explanation to the subject to allow the subject to participate in the clinical trial, and Article 51, Paragraph 1, Guidance 6 of the GCP and Article 2, Guidance 15 (1) (ii) of the GCP state that "it is desirable to combine the explanation document and consent document into a single document or a set of documents. The Guidance 6 of Paragraph 1 of the same Article and the Guidance 15 (1) (ii) of Article 2 of GCP state that "it is desirable that the explanatory document and the consent document be an integrated document or a single document.
Furthermore, GCP Article 2 Guidance 15 (1) (iii) states, "The consent document (omitted) should be handled as an integrated document or a set of documents with the explanation document, if the form is specified in advance. For example, when submitting an explanatory document to the head of the implementing medical institution in accordance with Article 10 or to the Clinical Trial Review Committee in accordance with Article 32, the explanatory document and the consent document should be submitted together.
In light of the above, it is more appropriate for the consent document actually used to be integrated with the explanatory document to ensure that the subject is given the explanatory document as well, which must be approved by the investigational review committee.
Therefore, it would be desirable for sites to prepare a consent document that has been approved by a clinical trial review committee (in the form of a photocopy that is integrated with the explanatory document), but because of time constraints in preparing such a document, the use of a consent document such as the one you are asking about seems unavoidable. However, in the case of a consent document that is stored separately from the explanatory document, it should be noted that the explanatory document received by the subject should be identified in the consent document (e.g., the date of creation and version number of the explanatory document).