Drug Evaluation Committee 2010-28 Necessity of Retention of Laboratory Test Requisition Slips
Related classification: Record keeping
First published: October 2010
Revised publication date: March 2021
Question
In some cases, the sponsor may request that the laboratory request slips generated when requesting an external laboratory to perform a clinical test and measurement are retained after the completion of the clinical trial. Some sponsors do not require such retention.
Our interpretation of the necessity of preservation is that in the case of outsourced testing, there is no record in the medical record that the test was performed.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "Documents and Records Pertaining to Clinical Trials" (August 31, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Life Sanitation Bureau, Administrative Communication, Evaluation and Management Division) does not mention the retention of test order slips, as you have mentioned.
However, the test order slips indicate that the site appropriately requested the testing company to perform the tests in accordance with the clinical trial protocol, and if there is any deviation in the handling of specimens (collection, processing, storage, transfer, etc.), it can be considered as a record of such deviation (GCP Article 46 Guidance 2). In addition, the regulatory authorities in Europe, the U.S. and other countries have established a system to record such deviations. In addition, it may be required to be presented at the time of GCP inspections by regulatory authorities in Europe, the U.S., and other countries.
Thus, while the retention of such inspection request slips is not stipulated in the Japanese GCP, the sponsor is likely to request the retention of such slips, taking into consideration the record of deviation from the study protocol and the possibility of inspections by regulatory authorities in Europe, the U.S., and other countries. Therefore, it is recommended to consult with the sponsor prior to the start of the clinical trial to determine the necessity of retaining the relevant inspection request slips.
Reason for revision of opinion
The reference notice has been changed in accordance with the issuance of "Documents and Records Pertaining to Clinical Trials" (August 31, 2020, Ministry of Health, Labour and Welfare, Pharmaceuticals and Life Sanitation Bureau, Office Communication, Evaluation and Management Division).