Drug Evaluation Committee 2004-07 Article on Compensation for Injury to Health for Contracting Parties and Contracts on the Sponsor's Side
Related classification: clinical trial contracting procedures
First published: December 2004
Question
We received the following question from a sponsor regarding a developmental clinical trial submitted to our hospital.
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1.Is it possible to name the contractor as "Managing Executive Officer and General Manager of the New Drug Development Division" instead of "President and Representative Director"?
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2.Is it possible to change the following clause in the "Agreement: Compensation for damage to the subject's health"?
"If it is caused by the gross negligence of the institution, it is the responsibility of the sponsor, Form A."
However, in the opinion of the sponsor, there should be no problem if the following definition of gross negligence is confirmed.
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Definition of gross negligence
Negligence on the part of a medical institution that results in: 1. health problems that result in death; 2. life-threatening or potentially fatal health problems; or 3. health problems that result in permanent disability.
Is there any problem in changing the wording of the contract from "when caused by gross negligence" to "when attributable to the A"?
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
About question 1
A clinical trial contract is a contract between a medical institution and a sponsor, so if a person is authorized to conclude the contract by an internal agreement, he/she can be the contractor even if he/she is not the head of the corporation.
About question 2
There is no problem in using the form of the sponsor. However, what you are considering as the definition of "gross negligence" as indicated in the second sentence relates to the degree (severity) of adverse events and is not related to the severity of "negligence" (serious adverse reactions occur regardless of whether there is negligence or not), and we think it is inappropriate as a definition of "gross negligence.
The definition of "gross negligence" or "negligence" is subject to legal interpretation, and there are currently no uniform standards.