Drug Evaluation Committee 2013-31 Handling of source documents whose originals are on thermal paper (Part 2)
Related classification: Record keeping
Initial release date: July 2014
Revised publication date: December 2021
Question
We are conducting a clinical trial of an anticoagulant drug for patients with PAD (Peripheral Arterial Disease) that is being conducted outside the heart. The primary evaluation of this clinical trial is the number of cardiovascular and cerebrovascular events, their content, and the time to onset. One subject had dysuria prior to entering the trial, and during the trial period, he visited a urologist, who diagnosed him with an "enlarged prostate". Uroflow and other tests were performed at that time. The test results were attached to the medical record on thermal paper. The monitor asked me to make a copy of it. So, I have a question. Do I need to make copies of all the thermal papers of test results and blood pressure readings from other departments as well? If copies are required, do I need to sign or otherwise sign there?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
If the originals are on thermal paper and cannot be stored for a long period of time, it is necessary to make a certified copy, which is defined in Article 2 Guidance 6 of GCP as "a copy or transcript that is certified by verification to be an exact copy". In other words, whether or not a certified copy needs to be made depends on whether or not the record is an original source, regardless of whether or not it is a record of another department.
The term "source documents" is defined in Article 2 Guidance 6 of the GCP as "documents, data and records (omitted) that are the source of information on the factual course of the clinical trial, case reports, etc." The term "source documents" is defined in Article 2 Guidance 6 of the GCP.
Therefore, if the case report of the clinical trial is to describe the tests (methods, results, etc.) in question, the records are considered to be source documents. In addition, in the case of your question, since the symptoms started before the start of the clinical trial and the diagnosis was made during the clinical trial, it is possible that the results of the Uroflow and other tests need to be preserved as the basis for judgment (records necessary for reproduction and evaluation of the factual process) as complications or adverse events of the subject in question. It is difficult to specify the details of source documents for complications and adverse events in advance, so if there is any doubt about the extent to which they need to be preserved as source documents, we recommend that you discuss this with the sponsor on an individual basis, taking the above into consideration.
Please refer to the previous Opinion 2011-54 (Handling of source documents whose originals are on thermal paper) for how to prepare a cetified copy.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (No. 0831-15 issued by the Pharmaceutical Affairs Agency on August 31, 2020).