Drug Evaluation Committee 2023-49: Transfer of Data from Source Documents to EDC
Related Category: Other
Initial Publication Date: February 2024
Question
We are contacting you to seek your opinion regarding the transcription of data from source documents to the EDC.[Question]
・When a CRC enters data into the EDC, is it necessary to transcribe the source documents (source data) in their entirety?
For example, among the data collected in the EDC, there are likely many data points (questions) where a third party can clearly determine the information simply by reviewing the medical records—such as whether an adverse event occurred (Yes/No), information on concomitant medications, whether hospitalization occurred and its duration, and whether a blood transfusion was administered—and where it seems the CRC could enter or answer the EDC without making any medical judgments.
Regarding such EDC questions, if the electronic medical record is identified as the source document in the Source Document Identification List, is it acceptable for the CRC to enter the data into the EDC without creating a worksheet?Or is it strictly necessary to transcribe the data verbatim, requiring a worksheet created so that there is a one-to-one correspondence between each question in the EDC and the response?
Of course, I understand that CRCs are prohibited from taking the actions described above if medical judgment is required when entering data into the EDC.
<Note>
・Regarding Clinical Trial No. 119, Document 2014-30: I understand your position to be that it is acceptable to transcribe Japanese entries from medical records into English in the source documents (provided no medical judgment is involved).
・Our current understanding is that EDC data entry must be performed by fully transcribing the source documents; however, we have received feedback from the field that the creation of a vast number of worksheets is placing a burden on sites, which led to the above inquiry. We would greatly appreciate your opinion on this matter.
JPMA Opinion
The “Basic Approach to Risk-Based Monitoring (July 5, Reiwa 1)” states that “Investigator Sites must prioritize the process management of clinical trials and implement appropriate measures to ensure the creation of accurate case report forms.” This requires the establishment of a process to accurately enter the contents of source documents into the EDC.Creating worksheets corresponding to each EDC field is one method for preparing accurate case report forms; however, even in this case, it is not considered necessary to create source documents (worksheets) that perfectly match every EDC input field.On the other hand, for fields that can be accurately entered into the EDC by reading the information in the medical records without requiring medical judgment, it is reasonable to consider an approach that does not involve creating worksheets. When a CRC enters data into the EDC using this method, the transcription must be performed without bias or speculation.We also recommend establishing detailed procedures as needed (such as which parts of the medical records to verify and how to handle cases where medical findings are identified).
Furthermore, in cases where information from medical records is entered into a worksheet, even if the worksheet is designated as the source document, there may be instances where the information in the medical records takes precedence, or where an explanation is required for inconsistencies between records. It is important to note that creating a worksheet does not always serve as a risk mitigation measure for producing accurate case reports.
It is advisable to review each medical institution’s medical record creation processes and policies, and to consider appropriate measures based on the risks associated with the data, taking into account its importance.