Drug Evaluation Committee 2012-01 Records to Assure Accuracy Control, etc. in Testing Laboratories
Related classification: Record keeping
First published: May 2012
Question
From April 2012, the sponsor will be required to confirm the accuracy control records of a laboratory. Are we obliged to keep such accuracy control records for the same period as the mandatory documents?
JPMA's Opinion
As stipulated in Article 4, Paragraph 1, Guidance 4 of the GCP, in order to assure that testing of specimens for a clinical trial is properly conducted in a laboratory (including laboratories, etc. of Investigator Site) and that data pertaining to the clinical trial are reliable, the sponsor must check the records, etc. that assure the accuracy control, etc. in such laboratory. As stipulated in Article 4, Paragraph 1, Guidance 4 of the GCP, in order to ensure that tests are conducted appropriately at laboratories (including laboratories at medical institutions) for specimens for clinical trials and that data pertaining to clinical trials are reliable, the sponsor must confirm records that guarantee accuracy control, etc. at such laboratories. In other words, the "records assuring accuracy control, etc." are important documents that support the reliability of the test data (original data), so these documents must be preserved during the period stipulated in Article 41, Paragraph 2 of the GCP.