Drug Evaluation Committee 2007-18 Signature Date of Consent Document
Related classification: Obtaining consent
Initial release date: Jan. 2008
Revised publication date: December 2021
Question
During the audit, the handwriting of the date on the consent document was pointed out. The joint signatures of the responsible (sub)physicians and the CRC had a single date entry field, and the CRC had filled in the date there.
Is it still a violation if the signature date is not handwritten by the physician responsible (or the CRC)?
Also, there was no indication that the medical record sticker was filled out by the SMO CRC in the hospital and stamped with a confirmation seal by the physician.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 52, Paragraph 1 of the GCP stipulates that "The consent stipulated in Article 50, Paragraph 1 or 2 (omitted) shall not be effective unless it is dated and signed by the investigator who provided the explanation and the person who is to be the subject. In addition, Article 52, Paragraph 1, Guidance 1 states, "If a cooperative investigator provides a supplementary explanation, the cooperative investigator must also sign and date the document.
Therefore, the prospective subject, the investigator, and the cooperator who provided the supplementary explanation must each sign and date the consent document.
The problem in your case is not that the CRC did not date the document, but that the investigator did not date it. It is necessary that each person who provided the explanation must date the document. To ensure that this is done in the future, we recommend that a space for the date be added to the signature line of each person in the consent document.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.