Drug Evaluation Committee 2013-01 Capturing Images for Transition to Electronic Medical Records
Related classification: Record keeping
Initial release date: May 2013
Revised publication date: March 2021
Question
Please tell us about the storage of radiographs from a clinical trial that has already been completed at a medical institution several years ago.
A medical institution that we (SMO) support has inquired whether it is acceptable to store radiographs (source documents) of subjects who participated in a clinical trial in the past by importing the image data into an electronic medical record instead of using photographs as the storage format. If there is no problem after importing the image data into the electronic medical record, they would like to destroy the photographs themselves.
According to Article 2 Guidance 6 of GCP, "source documents" refer to "records necessary for reproducing and evaluating the factual course of a clinical trial," and in principle, the original (original) documents are subject to preservation. However, for records that cannot withstand long-term preservation, such as thermal paper, "certified copies" can also be considered as source documents. The method to "guarantee that it is an exact copy by verification" is generally to date and sign the copy by the investigator and other related parties.
If the radiographs cannot be dated and signed, as is the case with the radiograph image data in this case, how should we deal with the situation? Or, if we consider the image data as the "negative" of the radiograph, is there any problem in destroying the radiograph itself as long as the image data is imported into the electronic medical record?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The concept of the past Opinion 2011-50 (Handling of Signed Consent Forms Digitized by Scanner) can be applied to the case where an X-ray image stored as a film is imported into an electronic medical record as an electronic image. In other words, if the "authenticity," "legibility," and "preservation" of the electronic image can be ensured, "verification assures that it is an exact copy," the electronic image can be regarded as an original instead of the original film, and there is no problem even if the film is destroyed, The date and signature on the photocopy are also not required, as is the case with certified copies of paper media.
As stated in "Guidelines for the Safe Management of Medical Information Systems, Version 5.1" (January 2021, Ministry of Health, Labour and Welfare), "9. In cases where diagnostic imaging is performed using high-definition information such as X-ray films, it is necessary to take care not to impede medical judgment, etc. due to a decrease in the volume of information. Therefore, it is necessary to fulfill this condition to ensure "reproduction of the factual course of the clinical trial," which is a necessary condition for source documents in a clinical trial.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020) and the "Guidelines for the Safety Management of Medical Information Systems Version 5.1" (Ministry of Health, Labour and Welfare, January 2021), minor revisions have been made to the questions and opinions.