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 JPMA website defines remote SDV as follows
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.
JPMA's Opinion
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
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.