Drug Evaluation Committee 2012-54 Screening of medical records before clinical trial contracting
Related classification: Other
First published: May 2013
Question
When a sponsor came to our hospital to investigate a clinical trial, we talked about the number of patients and I answered, "We have to pre-screen them out of the medical records," to which he said, "That is illegal in the industry now.
From my memory and subsequent reading, I do not see any such provision in the GCP or other relevant regulations. Therefore, I would appreciate it if you could respond to the following three points.
- Is it illegal to access medical records for pre-screening during the facility selection survey stage? (Naturally, people at our facility are free to access medical records regardless of such matters.)
- If illegal, what laws, notices, or guidelines are violated?
- If prescreening is not available, on what basis does the facility determine the contracted caseload?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As for your question, you stated that it is "industry-legal," but the Pharmaceutical Manufacturers Association of Japan (PMAJ) has not expressed such a view.
As a sponsor, we may inquire about the number of patients at our medical institution who are likely to participate in the relevant clinical trial as part of the selection of medical institutions, but we do not necessarily ask for prescreening from medical records. In some cases, we respond by asking the potential investigator for the approximate number of patients as a recent situation.
In the case of your question, the purpose is for the staff of the medical institution to understand the approximate number of patients by reading the medical records in order to understand the breakdown of patients (number of potential subjects) at their hospital, and it is not intended to provide any specific personal information. Therefore, there should be no problem as long as it is within the scope of the purpose of use of personal information indicated by the medical institution in question.