Drug Evaluation Committee 2009-09 SDV records created by monitors
Related classification: Other
First published: Jul. 2009
Question
Recently, some sponsors have been copying the entire medical record.
We thought that monitoring was to check the consistency between the medical record and CRF, but there are some monitors who copy the medical record word for word from morning to night without opening the CRF. However, there is a monitor who does not spread out the CRF and just copies the chart word for word from morning to night.
The supervisor was present and insisted that the GCP states that the company requires the monitor to copy the medical record, not just the monitor in charge of the case. The person also said that the CRO has also made such a request.
Furthermore, the storage of the copied paper was very careless, and when we pointed out the danger of dropping the report form regarding what was written on it, he responded that there was no problem at all because it did not have his name on it. The idea is that they are not concerned at all about the problems that would arise if such an item were to be lost in the hospital.
We believe that this kind of copying of medical records is very problematic. Although this case is extreme, similar cases do occur from time to time. I don't think the subjects expect that their personal medical records are being handled in this way.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Regarding the direct access you pointed out, Article 21, Paragraph 1, Guidance 1 of GCP states that "the sponsor shall ensure that the human rights of subjects are protected, their safety is maintained and their welfare is improved, the clinical trial is conducted in compliance with the latest study protocol and these standards, the clinical trial data reported by the investigator or sub-investigator are accurate and complete, and the source documents are accurate and complete. Monitoring is to be conducted to confirm that the clinical trial is being conducted in compliance with the latest protocol and these standards, and that the clinical trial data, etc. reported by the investigator or subinvestigator are accurate, complete and verifiable in light of the source documents and other clinical trial-related records.
Although it may be necessary to make photocopies, etc., to a limited extent from the source documents, depending on the contents of the study protocol and case report forms, the work you point out of continuously copying medical records word for word is an excessive practice. In addition, if a monitor loses the transcribed paper, whether inside or outside the hospital, even if the subject's name is not written on it, it is problematic from the standpoint of preserving the subject's confidentiality.
Originally, monitoring (SDV) is to verify whether the data described in the case report form are properly transcribed and evaluated from the source documents. Furthermore, we must not forget to verify that the clinical trial was properly conducted as a medical practice. It is necessary for each company to recognize once again that confirming the consistency of the case report by copying every word of the medical record is not the reliability required by GCP.