Drug Evaluation Committee 2022-34 Document explaining compensation for health hazards to test subjects
Related classification: clinical trial contracting procedures
Initial release date: January 2023
Question
Please provide information on the "Document Explaining Compensation for Health Damage to Subjects," which is used as a review document by the Board of Clinical Trial Examiners.
Our hospital uses the document submitted by the sponsor to the hospital director explaining the subject's compensation for adverse health effects as the review document. We understand that this is part of the ICF and is intended for patients.
I understand that this is a part of the ICF and is intended for patients. I have a client who has attached the items regarding compensation for health damage in the ICF as a separate document, which is also included in the Clinical Trial Review Committee's discussion document "Document explaining compensation for health damage to the subject.
Opinion of the Pharmaceutical Manufacturers Association of Japan (PMAJ)
The "matters concerning compensation for health damage" that should be included in the explanatory document are described in GCP Article 51, Paragraph 1, Items 12, 13, and 14. In addition, 3-2 of 3. Principles of Compensation in the "Guidelines for Compensation for Health Damage to Subjects" of the Institute of Biomedical Research and Innovation (IBRI) includes the following statement.
The sponsor shall prepare a document explaining the outline of the sponsor's compensation rules to the subject in an easy-to-understand manner (hereinafter referred to as "outline of compensation"). The sponsor shall request the investigators to include the fact that compensation will be provided in accordance with the compensation rules of the relevant clinical trial in the explanation and consent documents when the investigators explain to the subjects. The "Summary of compensation" shall be delivered to the subject by the investigator together with the explanatory and consent documents.
As described above, we believe that the explanatory document should state that "compensation will be provided in accordance with the compensation rules of the relevant clinical trial. In addition, as described above for the compensation regulations for each trial, we believe that "Summary of compensation" is often prepared as a separate sheet accompanying the explanatory document, but this guideline also states that it should be "a document that explains the subject in an easy-to-understand manner" and the content should be sufficient for patients who may be subjects to fully understand the compensation This is a good example of a "document that explains the contents in an easy-to-understand manner to subjects".
On the other hand, "a document explaining compensation for health damage to subjects," which is a clinical trial review committee review document, is stipulated in Article 32, Paragraph 1 of the GCP, but there are no specific provisions in the GCP regarding its contents. Therefore, if there is no particular regulation on the content of the document in the protocol of the clinical trial review committee, etc., and if appropriate review can be conducted, there should be no problem in combining the item on compensation for health damage in the explanatory document with the "document explaining compensation for health damage to subjects," which is a clinical trial review committee review document, as an attachment. We believe that this is acceptable.