Drug Evaluation Committee 2019-48 How to keep contact records with subjects
Related classification: Record keeping
Date of first publication: December 2019
Question
Many of the subjects who participate in clinical trials contracted by our company (SMO) are relatively young patients, such as those of the working generation. As time goes by, the frequency of exchanging information with subjects via smartphones is very high. In addition, we lend smartphones to all CRCs. In this context, the tools for exchanging information with subjects are diversifying, and we are struggling with how to keep records via cell phones (including smartphones) provided by subjects to CRCs.
Specific means include the use of short message services (SMS) and communication applications. It is more convenient for subjects who are working to exchange information via messages, etc., than via phone calls, and it is also easier for them to provide us with information. Currently, when information is provided by subjects via SMS or communication apps, for example, when a message is received that "I have been taking 00 medication since yesterday," the CRC in charge of the subject enters the information on some paper medium (worksheet, CRC memo, etc., to be used as source documents), and after having the physician confirm the information The CRC then enters the information on some form of paper (worksheet, CRC memo, etc., to be used as source documents).
- Example.
- 2019/12/04 The following information was provided by the subject
"I have been taking 00 medication since yesterday" 2019/12/04 Name of CRC
We would like to know your views on the following two points regarding these measures.
-
1) Number of reports and countries from which data was obtainedTo begin with, is it possible to save messages received via SMS or communication apps as source documents? For example, if we print out the screen of the email we received, it is only a copy and not an original source document, so I am not sure if it is preferable to use the method we are currently using at our company.
-
2)In the above case, whether it is necessary to keep a record of the medium (SMS or communication application) through which the information was obtained in order to clarify the location of the original source data.
- Example.
- 2019/12/04 The subject provided the following information via SMS:
"I have been taking 00 medication since yesterday" 2019/12/04 CRC Name
If records are kept by the means described in 2) above, the recorded paper media itself is considered a secondary document, and we also wonder if it is necessary to print out and save the screens and data of the communication application. The contents of information exchanged between subjects and CRCs may include information related to the privacy of the subjects, and printing of data should be avoided as much as possible. On the other hand, if we do not describe the means by which the information was obtained, we may not be able to "see how the information was obtained" in hindsight. As we are instructed to keep records that show how the information was obtained on a daily basis, we are not sure if we should also include the means of obtaining the information or not.
We have never had a sponsor mention this in an audit or SDV, etc. Please give us your opinion on a more appropriate way to handle this.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 1 Guidance 2 (10) requires all information related to a clinical trial to be recorded in a manner that allows for accurate reporting, interpretation and verification of all records, regardless of their media. Regarding your two questions,
-
1) Number of reports and countries from which data was obtainedWe believe that the method currently practiced (CRC writing information on paper media) is acceptable, but we also believe that a copy (printout) of the SMS, communication app, or other electromagnetic record can be considered a Certified Copy and be used as the original source data. When treating SMS or communication application history as a clinical trial record, it is necessary to share the understanding among investigators, subjects, and other related parties in advance.
-
2)When CRC records information on paper media, it would be desirable to record the information in such a way that it is clear how the information was collected from the subject.