Drug Evaluation Committee 2020-36 Medical Judgment by CRC Using Oral and Written Documents to be Included in Original Documents
Related classification: Record keeping
Date of first publication: December 2020
Question
This question is about whether or not a CRC can write medical judgments orally heard from a physician into source documents (dictation), which are then checked by the physician for final confirmation.
According to a notice issued in 2007 by the Ministry of Health, Labour and Welfare (MHLW), "Regarding the promotion of role sharing between physicians, medical professionals and administrative staff (December 28, 2007, Medical Affairs Bureau Director-General's Notice No. 1228001)," it is possible for administrative staff to write medical records and medical certificates if the physician gives final approval. The notice states that "office staff can fill in medical records and medical certificates if the physician gives final approval. Based on this notice, there are many facilities where clerical staff enter the information they hear orally from physicians in the vicinity of the physician's office into the electronic medical record as a proxy to improve operational efficiency. If clerical staff can enter medical records that contain a lot of medical judgment, we think there should be no problem for CRCs to enter items that involve medical judgment, such as adverse event worksheets, based on what they hear from physicians.
We would appreciate your opinion on this matter, as it would greatly contribute to reducing the amount of work physicians have to do in clinical trials and speeding up EDC input.
In addition, in the November 2018 newsletter posted on your website, it is stated that dictation is being conducted, which is incompatible with the answer to 2019-40.
http://www.jpma.or.jp/about/issue/gratis/newsletter/html/2018/88/88cm-07.html
Background
The question is slightly different, but in response to the question in 2019-40, "Is it appropriate for the CRC to enter EDC with medical judgment at the first record stage? The answer to this question was, "Medical judgment can only be performed by physicians in Japan. In 2011-21, the response was that "there is no problem for CRCs to enter matters on the worksheet that do not involve medical judgment.
Considering these two responses, it seems that the CRC is not allowed to enter adverse event worksheets (and subsequently enter EDC) for adverse events that have been orally reported by physicians, even if the physician makes the final confirmation.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
We do not see a problem with the CRC dictating the adverse event worksheet or other items that involve medical judgment based on the content of the physician's interview, rather than their own judgment. In this case, it would be better to document the procedure for preparing the original dictation (including the method of confirmation by the dictator) so that a third party can verify later that the dictation was prepared in accordance with the said procedure.
In addition, the past Opinion 2019-40 states that it is problematic to record medical judgment records (EDC input) under the name and responsibility of the CRC, which is within the scope of responsibility of the investigator, etc., because this is not a case where data is input from the source documents to the EDC, but data directly input to the EDC as the source documents. The Opinion 2011-21, on the other hand, states the following. On the other hand, in Opinion 2011-21, the case is to record observation and measurement data on the source worksheet prior to data entry into the EDC.