Drug Evaluation Committee 2010-46 How to Correct Original Documents
Related classification: Other
Date of first publication: February 2011
Question
Recently, we received a request from a sponsor, "If you correct the contents of original documents at a medical institution, we would like you to include the physician's seal, the date, and the reason." We received a request to do so. We have usually taken the same action with regard to case reports, but do we need to do the same with the original documents? We think this is an excessive response.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Source documents related to clinical trial data are important documents to ensure the reliability of clinical trial results. Therefore, sufficient consideration must be given to correcting the content of source documents.
In regard to medical records, which are one of the source documents, the "Guidelines for Provision of Medical Information" attached to the Notice of the Director-General of the Medical Affairs Bureau of the Ministry of Health, Labour and Welfare (Medical Affairs Bureau No. 0912001, September 12, 2003) states, "5: Ensuring the accuracy of medical records": "○ Correction of medical records must be made in a way that the person, content, date, etc. of the correction are known. The revision of medical records must be made in such a way that the person who made the revision, its contents, date and time, etc. can be identified. This is in line with the "5 Guideline for Ensuring Accuracy of Medical Records". In addition, the "Guidelines for the Handling of Personal Information Related to Medical Treatment" issued by the Japan Medical Association in October 2006 states, "3-3 Revision of Medical Records, etc.": "When a medical institution revises a medical record once made, it must cross out the original entry with a double line so that the original entry can be distinguished, and affix the date and the seal of the person making the revision at the place where the revision was made. The medical institution must take appropriate measures to make the fact of revision objectively clear, such as by crossing out the original entry with double lines so that it can be distinguished from the revised entry, and affixing the date and the seal of the person who made the revision to the revised part. The above is the purpose of the notice, etc., and the original.
Considering the purpose of the above notification and the impact that amending source documents may have on the reliability of clinical trial results, medical institutions are requested to amend not only medical records but also other source documents in an appropriate manner that they believe can be explained to a third party.