Drug Evaluation Committee 2008-24 Documents or records pertaining to clinical trials prepared in pencil
Related classification: Other
Initial release date: Jan. 2009
Revised publication date: December 2021
Question
GLP stipulates "recording in a manner that cannot be easily erased" in Article 28, Item 3*. However, if documents or records kept at the site are written in pencil, is it necessary for the sponsor to request that they be "recorded in a way that cannot be easily erased" as in the GLP? If so, what should be shown as the basis for such a request (e.g., laws, etc.)?
*: The relevant information is provided in the GLP of the Law Concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc. (Standards for Testing Facilities Conducting Tests on New Chemical Substances, March 31, 2011, Pharmaceutical Affairs Bureau No. 0331-8, March 29, 2011, Pharmaceutical Affairs Bureau No. 6, March 31, 2011, KANHOKEI No. 110331010). In addition, the same is described in 1 (13) (a) (i) of the enforcement notice of the Ministerial Ordinance on GLP for Pharmaceuticals (Ministerial Ordinance on the Standards for Conducting Non-clinical Studies on Safety of Pharmaceuticals, June 13, 2008, Pharmaceutical and Food Safety Bureau No. 0613007, regarding the handling of the Ministerial Ordinance on the standards for conducting non-clinical studies on safety of pharmaceutical products after its partial amendment. The same statement is made in (1)(i).
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
As stipulated in GCP Article 1, clinical trials must be conducted to ensure scientific quality and reliability of results, and GCP Article 1 Guidance 2 (10) stipulates that "all information regarding clinical trials shall be recorded, handled, and stored to enable accurate reporting, interpretation, and verification. GCP Article 1 Guidance 2 (10) states As one of the measures to ensure the reliability of the results, it seems to require "recording in a manner that cannot be easily erased" in order to reduce the risk of falsification or disappearance (due to intentional or negligent error) of clinical trial-related records.
Regarding case report forms, Article 47, Paragraph 2, Guidance 1 of the GCP states that "Any change or amendment to a case report form shall be dated and signed by the name...(omitted)..." and "Any change or amendment to a case report form shall be dated and signed by the name...(omitted).... In addition, the change or amendment must not obscure the original description (i.e., it must be preserved as an audit trail.) .... This applies to both document and electronic data changes or modifications". As a means of properly preserving such audit trails, it is appropriate to require "recording in a manner that cannot be easily erased" from the creation stage.
In addition to the above, the Medical Practitioners Law and the Regulations in Charge of Medical Treatment must be followed for medical records, etc.
Reason for revision of opinion
In accordance with the issuance of the GCP Guidance (July 30, 2021, Pharmaceutical Affairs Bureau of Japan, No. 0730-3), the opinion text has been partially changed.