Drug Evaluation Committee 2016-59 Records Assuring Accuracy Control, etc. in Laboratories (Part 2)
Related classification: Other
Date of first publication: June 2017
Question
We have a question regarding the retention of records to "ensure that tests are conducted appropriately and that data pertaining to clinical trials are reliable" under Article 4, Paragraph 1, Guidance 4 of the GCP.
Background
As records to "ensure that tests are conducted appropriately and that data pertaining to clinical trials are reliable," calibration, maintenance, and inspection of measuring instruments such as MRI and CT for the measurement of key endpoints are conducted. Although the implementing medical institution does not plan to keep the maintenance and inspection records and calibration records indefinitely and is considering destroying the records periodically, in units of several years, we believe it is necessary to keep the calibration and maintenance records during the clinical trial period as a record that the tests conducted during the trial period were performed with equipment that was appropriately calibrated.
However, maintenance and inspection records for imaging tests include not only those that indicate that maintenance and inspections were performed, but also those that describe the details of maintenance and inspections. If the tests performed during the clinical trial period indicate that proper calibration was performed, is it acceptable to dispose of the documents related to the details of maintenance and inspections every few years in accordance with the facility operation, since the contents of the inspections have not changed since the periodic inspections were performed?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In the attached "4. Maintenance and Inspection of Facilities and Measuring Equipment in Medical Institutions" of the "Basic Approach to Accuracy Control of Clinical Laboratory Tests in Clinical Trials" (Office Communication, Evaluation and Management Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, July 1, 2013), it is stated that "maintenance and inspection of various medical devices in medical institutions are regulated by the Medical Service Act, Measurement Act The accuracy control required in a clinical trial is regulated by the Medical Service Act and the Measurement Act, etc. The accuracy control required in clinical trials is sufficient if only the calibration and maintenance inspections normally performed in medical institutions can be checked when necessary and if the records of such inspections can be checked and properly managed. The above is stated as "the accuracy control required in a clinical trial is sufficient if the records can be checked when necessary and are properly managed.
However, the extent to which records should be kept as documents related to the clinical trial for the necessary period is determined by the position of each test data (medical device) in the clinical trial, such as whether they are related to the main endpoints. The sponsor may make a different judgment. Since the decision may differ depending on the sponsor, it is recommended that the sponsor and the site should discuss and agree on this matter.