Drug Evaluation Committee 2016-20 Definition of Remote Monitoring
Related classification: Other
Date of first publication: August 2016
Question
The following requests for remote monitoring were received from two companies.
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Company A
The sponsor wants to conduct "remote monitoring," in which the CRC responds to the monitor by telephone, in addition to the usual SDV.
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Company B
The data downloaded by the CRC to a dedicated system has been checked at the hospital at the time of SDV, but from now on, the company wants to conduct "remote monitoring" to view the data in-house.
The "Recommendations for Efficient Monitoring (April 2013)" on the website of the Pharmaceutical Manufacturers Association of Japan (PMAJ) includes the following definition of remote SDV.
Type A: A method of viewing a medical institution's electronic medical record through a dedicated security system.
Type B: A method to view a medical institution's paper medical record or typed out electronic medical record in PDF format via a dedicated security system.
Is it safe to assume that the requests from Company A and Company B are for remote monitoring or remote SDV? I was wondering because we do not use a dedicated system, but rather the usual SDV support with regard to medical records. I asked this question because I would like to clarify the definition of remote monitoring in the future.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP does not define remote monitoring, but as stated in Article 21, Paragraph 2 of GCP, on-site monitoring is monitoring "conducted at the site of the implementing medical institution," and as stated in Article 21, Paragraph 2, Guidance 2 of GCP, "when monitoring can be sufficiently conducted by other means," remote monitoring (off-site monitoring) is defined as monitoring "conducted at the site of the implementing medical institution. Remote monitoring (off-site monitoring) is considered to be "when monitoring can be adequately conducted by other methods. Unlike on-site monitoring, which has been the mainstream in Japan in the past, remote monitoring is conducted using telephone, web conferencing, e-mail, etc. as a means of communication.
In addition, there are two types of remote SDV, as indicated in the "Recommendations on Improving Monitoring Efficiency (April 2013). Remote SDV is a form of SDV, and since SDV is conducted as part of monitoring, remote SDV is encompassed by remote monitoring.
Therefore, the monitoring methods requested by Company A and Company B fall under the category of remote monitoring.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0705-3), minor changes have been made to the description.