Drug Evaluation Committee 2009-54 Response to Errata in Records
Related classification: clinical trial contracting procedures
First published: April 2010
Question
When a mistake is found on a document, there are two possible ways to respond to the mistake. One is to replace the document, and the other is to leave the mistake in the monitoring report if it is a minor one. When a monitor suggests that a document be left in the monitoring report, we sometimes have a hard time deciding whether we should replace it or not. Basically, we ask them to replace it.
This time, there was an error in the name of the physician on the "List of investigators and collaborators" submitted for initial review by the Clinical Trial Review Committee. The name of the investigator on the contract was also incorrect. The contract was replaced, but the monitor suggested that the list be retained in the monitoring record. What is the level of judgment on the part of the sponsor to leave the list in the monitoring report? If there are any basic criteria, please let us know.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stated in Article 1, Guidance 2 (10) of the GCP, all information related to a clinical trial must be recorded, handled, and stored in a way that allows for verification. Therefore, in all of the cases you mentioned, it is basically necessary to take steps to clearly show how the erroneous information was corrected. Please refer to our previous opinion ( 2009-18 ), which may be helpful.
In addition, monitoring reports are records stipulated in GCP Article 22, Paragraph 2, and are handled as records related to the relevant clinical trial. If there are any deficiencies in the records obtained from the site, the measures taken and the opinions of the monitors should be described in accordance with Article 22, Paragraph 2, Guidance 2 of the GCP.
The monitoring report is a record prepared and kept by the sponsor, and if, as in the case of the inquiry, the sponsor does not replace, issue a corrected document, or correct the document in response to an error in the document issued by the site, and only records the error in the monitoring report, the site will not be required to take any other action. In such a case, the medical institution needs to keep a separate record of the error.