Drug Evaluation Committee 2017-17 Matters to be included in the Consent Document
Related classification: Obtaining consent
Initial release date: Jul. 2017
Revised publication date: March 2021
Question
Is it sufficient for the subject to sign his/her own name and the date of consent in the consent document?
Our 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 did not include the postal code and address across the board. We would like to confirm that there is no problem under GCP even if the address is not written on the consent form.
JPMA's Opinion
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
The partial revision of the GCP Ministerial Ordinance (December 25, 2020) removed the need to affix a name and seal to the consent form.