Analysis of Standardization of Clinical Trial Contract Audit from the Perspective of Subject Protection / 中国医学伦理学

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.