Drug Evaluation Committee 2012-28 Use of stamp-type simple seals (ink penetrating seals) in clinical trial procedure documents
Related classification: clinical trial contracting procedures
First published: November 2012
Question
Although a seal is not required for clinical trial procedure documents (unified form for requesting a clinical trial, etc.), a simple stamp type seal (ink penetrating seal) is sometimes used to indicate that the investigator and site have checked the original document, as long as it is clear that it is the original. I feel that a simple seal is of little use even if it is stamped, but is it valid?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
On March 7, 2012, the "New Uniform Form for Requesting a Clinical Trial" was issued, which allows the omission of the seal upon consultation between the sponsor and the investigational site. In response to this, the Japan Pharmaceutical Manufacturers Association (JPMA) Clinical Evaluation Committee and the Electronic Information Committee presented their ideas on May 22, 2012. In (Commentary) 1 of the basic policy of this approach, it is stated that "It is important from the standpoint of reliability that the creator of the delivered document, the time of delivery, the destination of submission, etc. are appropriate and that the presence or absence of modification can be verified. These points can be verified by checking the documents stored at the source or destination of delivery, regardless of whether they are stamped or not, and by checking the actions and records that occur as a result of the delivered documents (e.g., a series of records from the request form to IRB deliberations, IRB minutes, notification of review results, and contracts)." (2) The "IRB" is not a "request form" but a "record".
Based on the above approach, we believe that there is no problem if reliability is ensured from the clinical trial procedural documents and the series of documents or records, etc. preserved, regardless of the type or presence or absence of a seal to indicate that they were verified.