Drug Evaluation Committee 2009-22 Data Entry into Case Report Forms and Preparation of Documents or Records Pertaining to Clinical Trials Using Water-based Ink Pens
Related classification: Other
First published: January 2010
Question
This question is about filling in case report forms and all documents related to clinical trials.
The GLP-related notice stipulates that raw data should be recorded "by a method that cannot be easily erased ... (abbreviation) ... record," and I think that the description with a ballpoint pen applies to that, but I think there are two types of ink currently in mainstream use for ballpoint pens: oil-based and gel-based ink. Gel ink is said to be water-based and soluble in water, but can it be used for case report forms and all documents related to clinical trials? I have done some research but have not been able to find a clear and definite answer.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
GCP Article 47, Paragraph 2, Guidance 1 states "Changes or modifications must not obscure the original description (i.e., they must be preserved as an audit trail). This is in reference to changes or modifications. Although this is a statement regarding changes or amendments, we believe that the same applies to the initial entry in the case report form and other clinical trial-related documents.
We do not know how much the description using gel ink will become indistinct when it comes into contact with water, but from the standpoint that it must be legible for the required period of time as a medical and clinical trial record, we suggest that you use a ballpoint pen with oil-based ink.