Drug Evaluation Committee 2018-40 Documents or Records pertaining to Clinical Trials Prepared in Pencil (Part 2)
Related classification: Record keeping
Date of first publication: January 2019
Question
This question is regarding how to correct a patient diary with data entered in pencil. This is a clinical trial in which self-glucose measurements are entered in the subject's logbook. The investigator, etc. checks the contents of the logbook at each prescribed visit to the hospital and enters the date signature.
Only two days out of 28 days of patient diary entries, i.e., a small portion of the data, were filled in with pencil, but the patient was unable to notice this on the day of the visit. During on-site monitoring nearly a month later, the monitor asked the investigator and others to overwrite the data with a pen and erase the pencil with an eraser on the next visit to the subject.
In a case like this, we do not feel that the method of correction requested by the monitor is justified, and we have considered the following method of correction. Is this method acceptable under GCP? Are there other more efficient and legitimate ways to make the correction?
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The CRC makes a photocopy of the relevant page of the logbook that has a partially penciled-in section.
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The CRC makes a "Certified copy" signed by the CRC with the date of the photocopy, and keeps it with the original penciled-in logbook.
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Ask the subject to complete the logbook in pen in the future.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
All information related to clinical trials must be recorded, handled, and stored in a manner that allows for accurate reporting, interpretation, and verification (GCP Article 1 Guidance 2 (10)).
In addition, ICH-GCP (R2) 4.9.0 states that the investigator must maintain adequate and accurate source documents with respect to each subject at the site and that the source data must meet attribution, legibility, contemporaneity, originality, accuracy and completeness, and further, if the source data is changed, The data must be traceable back to that process and must not obscure the description before the change.
Data entered by pencil can be modified without leaving a trace (audit trail), and is therefore not an appropriate method for recording data. It is also not suitable for long-term storage. In the case of accidental pencil entries, we believe it is appropriate to retain both the "Certified Copy" and the penciled original, as described in your question.