Drug Evaluation Committee 2017-17 Matters to be included in the consent document
Related classification: Obtaining consent
Initial publication date: 2017-07
Revised publication date: Mar 2021
Question
Is it sufficient for the consent document to be self-signed with the date of consent and the name of the subject?
Our hospital's consent document is a form that also includes zip code and address, and we asked to be informed that this item is not required. I checked the consent forms of other medical institutions and found that they do not include the postal code and address. We would like to confirm that there is no problem under GCP even if the address is not written on the consent form.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 52, Paragraph 1 of the GCP states that "a document stating consent to participate in a clinical trial shall not be effective unless it is dated and signed by the person who is to be the subject of the clinical trial.
Therefore, the consent document must indicate the date and the place to sign. On the other hand, GCP does not stipulate the necessity of stating other information (e.g., address) regarding the prospective subject, so stating the address is not mandatory. We believe that the investigator should determine the necessity of such information.
Reason for revision of opinion
The name and seal were deleted in accordance with the partial revision of the GCP ordinance (December 25, 2020).