Discussion on standardizing informed consent to improve the quality of clinical trials
规范知情同意书对提高临床试验质量的探讨

摘要

目的 对临床试验中知情同意书的不规范问题进行探讨，并提出规范知情同意书的对策，以提高临床试验的整体质量。方法 对临床试验的质量控制过程中发现的问题进行总结归纳，分析问题产生的原因，给出解决对策。结果 临床试验中知情同意不符合GCP要求的情况主要有知情同意书的内容设计问题、知情同意书版本问题、知情同意书研究者授权问题、知情同意书的签署问题、知情同意书时间逻辑问题。结论 知情同意书是保证临床试验质量的关键环节，是保护受试者权益和安全的重要手段，规范知情同意书有助于提高临床试验整体质量。

Abstract

Objective In order to improve the overall quality of clinical trials, the nonstandard informed consent form was discussed, and the tactics to standardize informed consent form were put forward.
Methods Summarize the problems found in the quality control of clinical trials, analyze the causes of the problems and give solutions.
Results Informed consent in clinical trials does not meet the requirements of GCP, mainly including the content design of informed consent, the version of informed consent, the authorization of informed consent researchers, the signing of informed consent and the time logic of informed consent.
Conclusion   Informed consent is a key link to ensure the quality of clinical trials and an important means to protect the rights and interests of subjects. Standardizing informed consent is helpful to improve the overall quality of clinical trials.