Drug Evaluation Committee 2023-49 Transcription of Original Documents to EDC
Related classification: Others
Initial release date：February 2024
Question
I would like to ask for your opinion on the transcription of source documents to EDC.Question
When a CRC enters data into an EDC, is it necessary to completely transcribe the source documents (original data)?
For example, there are many data (questions) collected in EDC that can be clearly read by a third party by viewing the medical record, such as the occurrence or non-occurrence of adverse events (Yes/No), information on concomitant medications, presence or absence and duration of hospitalization, presence or absence of blood transfusions, etc., and that CRC can enter/answer in EDC without making medical judgments. I think there are many data (questions) that CRC can enter/answer in EDC without medical judgment.
For such EDC questions, by identifying the electronic medical record as the source document in the source document identification list, is it acceptable for the CRC to answer (EDC entry) without the need to prepare a worksheet? Or is it necessary to strictly perform a complete transcription, and a worksheet must be created so that the answers are one-to-one for each question in the EDC?
Of course, if medical judgment is involved in the EDC entry, the CRC is prohibited from taking the above steps.
<Remarks.
I understand that it is not a problem to transcribe the Japanese description in the medical record in English (as long as it does not involve medical judgment) in the English description of the original documents in Clinical Trial 119, 2014-30.
However, we have heard from some sites that the creation of a huge amount of worksheets is burdening their facilities, and we would appreciate your opinion on this question.
The Pharmaceutical Manufacturers Association of Japan (PMAJ)'s Position
In the "Basic Approach to Risk-Based Monitoring (July 5, 2027)," it is stated that "medical institutions should implement appropriate measures to ensure that accurate case report forms are prepared, with an emphasis on clinical trial process management. One of the ways to create an accurate case report form is to create a worksheet for each EDC item, but even in this case, it is not necessary to create a source document (worksheet) that exactly matches all of the EDC entry items. However, even in this case, it is not necessary to create a source document (worksheet) that exactly matches all EDC entries.On the other hand, for items that can be accurately entered into the EDC without medical judgment by reading the information in the medical record, it is possible to consider a method in which no worksheet is created. In this method, when the CRC enters the information into the EDC, the transcription should be done without bias or guesswork. It is also recommended that a detailed process (e.g., where to check the medical record, what to do when a medical finding is recognized, etc.) be agreed upon, if necessary.
In some cases, information in the medical record may take precedence over information in the worksheet, even if the worksheet is designated as the source document, or an explanation may be required regarding inconsistencies between records. It should be noted that the creation of worksheets does not uniformly constitute a risk mitigation measure for creating accurate case reports.
It is advisable to check the process and policies for creating medical records for each medical institution and consider how to respond based on the risks, taking into account the importance of data and other factors.