加强药物临床试验病案的规范化管理

To Strengthen the Standardization Management of Medical Records of Drug Clinical Test

一份规范、完整的药物临床试验病案是保证药物临床试验质量的前提和基础。本文从参与药物临床试验人员的资格准入、病历书写质量、病案质量管理三个方面叙述规范药物临床试验病案管理的具体做法。

A standard,complete medical record of drug clinical test is the premise and basis for ensuring the quality of drug clinical test.This article narrates the concrete practice for standardizing medical records management of drug clinical test from the qualification of person participating drug clinical test,quality of medical records writing and quality management of medical records these three aspects.