Drug Evaluation Committee 2009-47 Costs incurred after the clinical trial period
Related classification: Principal investigators, subinvestigators, etc.
First published: Mar. 2010
Revised publication date: Apr. 2013
Question
The contract period of a certain study is until February 28, and the termination report is scheduled to be presented at the Investigational Review Board (IRB) meeting in April. The period will not be extended.
The sponsor is of the opinion that the trial will be completed by February 28 and that expenses incurred after February 28 (IRB fees, CRC travel expenses, etc.) may be charged even if the contract period has expired.
Is this a view that could be explained in an audit? Also, I don't think that GCP does not mention that much, but I would appreciate it if you could also explain your view in relation to GCP.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
In Article 13, Paragraph 1, Item 7 of GCP, the matter required to be stated in the clinical trial agreement is "the duration of the clinical trial" (see past Opinion 2007-16 ), which is usually considered to be different from "the period during which costs related to the clinical trial are incurred," including IRB fees at the end of the clinical trial, as in your question.
Regarding the payment of money related to the clinical trial, I assume that a contract has been concluded as stipulated in GCP Article 13, Paragraph 1, Item 12, "Matters Related to Costs of Clinical Trials," and the payment will be handled in accordance with the contents of that contract. If there are any matters that are not included in the contract, or if there are any unclear points regarding the handling or interpretation of such matters, there should be no problem in having the sponsor and the site discuss and confirm the matter with each other.
Reason for revision of opinion
The reference clause has been changed in accordance with the revision of the GCP Ministerial Ordinance (Ministerial Ordinance No. 161 of the Ministry of Health, Labour and Welfare issued on December 28, 2012).