关键词: 受试者/参与者补偿, 发放平台, 知情同意书, 资质要求, 风险预案

Abstract: In drug clinical trials， the sponsors and the investigators should timely pay the compensation or compensation given to the subject 《Good Clinical Practice》 (GCP， 2020 version)， which is an important concern of the ethics committee to protect the rights and interests of the subjects/participants， and is also a statutory duty to be performed by the sponsors and investigators. Subject/participant compensation payment platform (hereinafter referred to as“payment platform”) is a class of E-services platform with the function module of application， audit， payment， and supervision of subject/participant compensation， which can help the sponsors and investigators to audit the payment of compensation to the subjects/participants in time and improve the efficiency and traceability of compensation payment. Based on the survey of nearly 400 institutions using the payment platform， and the opinions of representative of the investigators， ethics experts and sponsors， on the basis of discussing the compensation payment model based on the subject/participant compensation payment platform， the“expert consensus on compensation payment platform for subjects” (hereinafter referred to as the“Consensus”) was formed. The consensus emphasizes ①the importance of including relevant information about the payment platform in the informed consent form； ②presents specific requirements for the qualifications of the payment platform， the payment process， and the preparation of agreements； ③the importance of protecting personal information and the establishment of risk emergency plans. This consensus aims to provide guidance for the implementation of compensation payment models for subjects/participants， serve as a reference for the industry， and promote continuous improvement of this model.
  

Key words: Subject/participant compensation, Distribution platform, Informed consent form, Qualification requirements, Risk emergency plan