Drug Evaluation Committee 2011-54 Handling of source documents whose originals are on thermal paper
Related classification: Record keeping
First published: Apr. 2012
Revised publication date: December 2021
Question
Source documents printed on thermal paper, such as electrocardiograms, are not suitable for long-term storage, so they are usually photocopied and stored. We consider the test results printed on thermal paper as originals and ask the physician to sign directly on the thermal paper as a record of his/her confirmation of the test results, and we keep a photocopy after the signature.
Some clinical trial sponsors make a copy of the test result and ask for the physician's signature on the copy. Is our hospital's response incorrect?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
ICH GCP 4.3 (see below) stipulates the medical responsibilities of the investigator or subinvestigator (hereinafter referred to as "investigator, etc.") to the subject. Based on this regulation, it is common in international clinical trials for the investigator to date and sign the examination chart or examination report as evidence that the investigator, etc. has performed the medical evaluation. Therefore, it is not wrong to have the signature directly on the thermal paper.
On the other hand, as stated in Article 2 Guidance 6 of GCP, "source documents" refer to "information related to the factual progress of the clinical trial," and in principle, the original documents (originals) are the subject of preservation. However, for records that cannot withstand long-term preservation, such as thermal paper, a "certified copy" (in ICH GCP, "certified copy") can be considered as source documents if it is verified that it is an accurate reproduction. Although the GCP does not specify a specific method for verifying that the copy is an exact copy, it is common practice to date and sign the copy.
There is no unified method for making certified copies of original documents on thermal paper and complying with ICH-GCP 4.3, but the following methods are possible
Method 1
- The original (on thermal paper) should be dated and signed by the investigator or subinvestigator to indicate that "medical evaluation has been performed".
- A copy shall be made from the original with the above date and signature, and the person who made the copy (not only the investigator, subinvestigator or collaborator, but also the person who guarantees that it is an exact copy) shall date and sign the copy to indicate "that the copy is a copy that does not differ from the original" and keep it with the original.
The following method may be considered when making a copy of the original (thermal paper) before the medical evaluation by the investigator or sub-investigator.
Method 2
- When a medical evaluation is performed, the investigator or subinvestigator should date and sign the copy (or both) and retain the original (thermal paper) with the certified copy to indicate both that this is the case and that it is a copy that does not differ from the original.
Please discuss with the sponsor a good method according to the hospital's procedures for making a copy.
Reference: ICH-GCP 4.3 Medical Care for Subjects
4.3.1
The investigator or subinvestigator, who is qualified as a physician (or dentist, as the case may be), shall be responsible for all medical (or dental) decisions related to the clinical trial.
4.3.2
The investigator/investigator shall ensure that adequate medical care is provided to the subject for all adverse events, including laboratory abnormalities of clinical concern related to the clinical trial, during the subject's participation in the trial and thereafter.
Reason for revision of opinion
The opinion has been partially changed in accordance with the issuance of the GCP Guidance (August 31, 2020, Pharmaceutical Affairs Council of Japan, No. 0831-15).