Drug Evaluation Committee 2018-54 Necessity of stating the amount of the cost-sharing reduction for subjects in the explanation document
Related classification: Obtaining consent
First published: Mar 2019
Question
We would like to ask whether or not it is necessary to specify the amount of burden reduction expenses in the explanatory document for subjects.
The explanatory document for subjects states only that a predetermined amount of money will be paid at the end of the clinical trial, taking into consideration the duration of participation, etc. based on hospital regulations. Although the approval of the Clinical Trial Review Committee has been obtained, it seems that the requirements of GCP Article 51, Paragraph 1, Guidance 1 (17) are not met because the amount to be paid and the calculation criteria are not specifically stated. Please tell us whether or not it is mandatory to include the specific amount of burden reduction expenses in the explanatory documents.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
Article 51, Paragraph 1, Guidance 1 (17) of the GCP states that "If money or other payments are made to subjects, the details of such payments (e.g., arrangements for calculating the amount of payment)" should be included in the explanatory documents provided to subjects. Therefore, in order to clearly inform subjects of the details of payment, it is important to include specific details of payment (e.g., the amount of payment per visit) in the explanatory document.