Drug Evaluation Committee 2013-11 Procedures to prevent alteration of sponsor's dossier when omitting the seal of the clinical trial procedure dossier
Related classification: clinical trial contracting procedures
First published: Jul 2013
Question
Based on the recommendation of the Drug Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (hereinafter referred to as "Pharmaceutical Manufacturers Association of Japan") dated May 22, 2012, the process of omitting the seal of the medical institution (seal of the head of the medical institution, principal investigator, chairman of the clinical trial review committee, etc.) should be indicated in some document such as a procedure manual, etc. I believe that some facilities have already omitted the seal. 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)?
Opinion of the Pharmaceutical Manufacturers Association
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 recommendation of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association (PMA) 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.