Drug Evaluation Committee 2014-10 How to state reasons for amendments in original documents and case reports
Related classification: Other
Initial release date: July 2014
Revised publication date: December 2021
Question
This section is about how to respond to erroneous entries on worksheets and CRFs.
Normally, when there is an error, we ask the physician to write "Correction of error" and to write the date and name of the error. However, we have received a consultation from a physician asking if we can use a rubber stamp for the "Correction of Error" statement. The date and name are still written in my own handwriting. It may depend on the sponsor, but I would be very interested to hear your opinion.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In Article 47, Paragraph 2, Guidance 1 of GCP, it is stipulated that changes or amendments to the case report form "shall be in accordance with the guidance provided by the sponsor or prepared by the person conducting the clinical trial on his/her own initiative," and "significant changes or amendments shall be accompanied by an explanation. The date and name of the person who made the amendment must be indicated.
Since the date of correction and the person who made the correction can be identified by the date and the name, it is considered unnecessary to write "Error correction" (rubber stamp) unless it is stipulated in the instructions prepared by the sponsor.
If the "Error correction" is indicated for some reason, there is no problem in using a rubber stamp since it is not a regulated matter. In such cases, care should be taken to avoid the use of a rubber stamp for "correction of errors" for important corrections that should be explained.
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.