Abstract: The CONSORT statement which published first in 1996 meant a consolidated standards of reporting trials and comprised a checklist and flow diagram. The checklist and diagram were primarily intended for use in writing, reviewing or evaluating reports of parallel group randomized trials. The statement was a continually-evolving document. The revised CONSORT statement was presented in 2001 and 2010. More than 400 journals and three leading editorial groups across the world have now given their official support to CONSORT. The latest version, CONSORT 2010, improves the specificity and clarity of the previous checklist. Based on introducing the background, processes of forming CONSORT statement and reviewing the contents and requirements of CONSORT, we prepared this paper, hoping to improving the quality of reporting randomized controlled clinical trials in our country. Some comments and suggestions were given at the same time.

Key words: Clinical trial, Randomized controlled trial, CONSORT statement