Drug Evaluation Committee 2009-23 Lost Original Signed Consent Form
Related classification: Record keeping
Initial release date: January 2010
Revised release date: December 2021
Question
The original consent form (first photocopy) was found to be lost at the time of the subject's first SDV. However, no action was taken because a photocopy was kept for storage in the Pharmacy Department and it was confirmed that consent had been obtained. Would it be a GCP non-conformity if only a copy of the consent form was kept? Also, is it necessary to obtain consent again? (Record the history of the consent by adding a comment such as "Consent was obtained on ●●● date").
I think this is a problem with medical record keeping at medical institutions, and we have asked for improvement.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 41, Paragraph 2, Item 2 of the GCP, the consent document must be kept by the person in charge of record keeping at the medical institution for the period stipulated in the GCP. Since it is said that a copy of the consent document is preserved, it is considered to be a record that explains the fact that written consent was obtained, but it does not change the fact that there was a deficiency in the preservation of records by the executing medical institution. It is necessary to record the fact of the loss and the circumstances surrounding the loss, and request that the implementing medical institution reconsider its document storage system.
As a measure to deal with the loss of the consent document, it may be possible to obtain the subject's cooperation in obtaining the date and signature on a record explaining that the subject consented in writing at that time.
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.