Analysis of Standardization of Clinical Trial Contract Audit from the Perspective of Subject Protection
10.12026/j.issn.1001-8565.2017.09.17
- VernacularTitle:从受试者保护角度浅析临床试验合同审计的规范化
- Author:
Xiaojuan YANG
1
;
Meiyou LIU
;
Xiaoxiao WU
;
Li PENG
;
Ying ZHANG
;
Yanyan JIA
;
Aidong WEN
Author Information
1. 第四军医大学西京医院药剂科
- Keywords:
Clinical Trial;
Contract Audit;
Subject Protection
- From:
Chinese Medical Ethics
2017;30(9):1133-1136
- CountryChina
- Language:Chinese
-
Abstract:
Carrying out clinical trial contract audit can audit the authenticity,legality and effectiveness of the contract and timely avoid the potential risks,clarify the responsibilities,rights and obligations of all parties participating in the clinical trials and clear the responsibility of each party in protecting the subjects,guarantee that the contracts include contents of subject protection and put them into practice.From the perspectives of establishing relevant documents,defining the main implementer,making the process,and confirming the core elements,this paper introduced how Xijing Hospital standardized clinical trial contract audit and expounded its significance in promoting the protection of subjects.
