Drug Evaluation Committee 2020-26 Temperature control record of investigational drug
Related classification: Investigational drugs
First published: October 2020
Question
Please tell us about the temperature control records for investigational drugs prepared by the site.
Background
We receive handwritten temperature control records of investigational drugs from the site. However, the record does not include a record of temperature checks on Saturdays and Sundays, nor does it include the maximum and minimum daily temperatures, and it does not meet the requirements for the temperature control record for study drugs. As an alternative record, the CRA would like to convert the original data from the temperature logger provided on the website by the site to a graph (PDF) of the temperature record using dedicated software, and store it in the TMF.
However, we have raised doubts within our company as to whether the temperature control records converted by the CRA can be regarded as official records, even though the original data is provided by the implementing medical institution. The reason is that "when a third party views the records during an audit or inspection, etc., they may not understand that the temperature control records (converted by the CRA) that are not provided by the executing medical institution are the temperature records of the executing medical institution. On the other hand, there are clinical trials in which temperature control records converted by CRAs are treated as official records within the company, so we are at a loss to decide.
Question
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1.Can temperature control records converted by the CRA be considered official records?
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2.If there is a problem with the above, is it possible to have the investigational drug manager at the site review the temperature control record converted by the CRA and sign the record so that it can be considered an official record?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The medical institutions are responsible for temperature control of drugs used in clinical trials at the implementing medical institution and the preparation of such records. From the perspective of ensuring the reliability of data and the proper division of responsibilities and roles in a clinical trial, it is undesirable for the sponsor to be directly involved in this process. If, for some reason, the sponsor needs to process the temperature control record of the investigational drug prepared by the site, the processing procedure and data storage method should be defined in advance in a procedure document specific to the clinical trial and agreed upon by both the sponsor and site (investigational drug manager). In addition, if it is technically possible to change data during processing, measures to ensure the reliability of the data would be necessary.
In addition, software available on the Internet may not be guaranteed to work by the provider. Software used for data processing in clinical trials should be validated and records should be kept so that they can be accounted for later.