Drug Evaluation Committee 2013-11 Procedures to prevent alteration of sponsor's dossier when omitting clinical trial dossier stamp
Related classification: Clinical trial contract procedures
First published: July 2013
Question
Based on the recommendation of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) dated May 22, 2012, the omission of the seal of the medical institution (seal of the head of the medical institution, principal investigator, chairperson of the clinical trial review committee, etc.) has already been implemented at some facilities after the process is indicated in some document such as the procedure manual. The above recommendation is based on the process of omitting the seal from the medical institution's side.
In the above recommendation, the omission of the seal on the medical institution side is described, including the proposed operation, but the omission of the seal on the sponsor side is not specifically described. Therefore, in order to operate without a seal, it is necessary not only to present the process for omission of a seal on the part of the medical institution, but also to confirm the process for omission of a seal on the part of the sponsor in some form when accepting a request for omission of a seal from the sponsor. We believe that the process of omitting the sponsor's seal must be confirmed in some way. Could you give us your opinion on the operation of the omission of the sponsor's seal (how to present the process of omission of the sponsor's seal to medical institutions)?
JPMA's opinion
Since clinical trial procedural documents are transferred from both the site and the sponsor to the other party, we believe that the "introduction of a process to prevent document alteration" described in the JPMA Drug Evaluation Committee's recommendation in your question is necessary not only for the site but also for the sponsor. In addition, since the basic policy states that agreement with the site is a prerequisite for omitting the seal, the sponsor must be able to present its own process to the site if the site requests it.
If you need to confirm the process of the sponsor, please contact each sponsor individually.