High quality clinical trial depends on the preliminary research design and optimizing, the quality control in the medium term, the source data verification and statistics in later stages. Steering committee (SC) can meet above requirements. According to the characteristics of the research project, we invited international experts whose professional background are obstetrics and gynecology, statistics and methodology to set up SC. SC will hold regular conference, the content of the conference included project progress and quality control, research assistant training and assessment, conducting knowledge lectures and so on. The establishment of SC ensured the protocol maneuverability, answered PCOS related problems from different professional perspectives, and solved the problems such as how to improve the scientific research output. At the same time, it provides a platform of scientific research practice and self-improvement. It has profound influence on standardizing the management of the clinical trial, strengthening the consciousness of team work, promoting multi-disciplinary team cooperation, expanding scientific research thinking and cultivating clinical research talent.
Medication adherence will directly affect the validity of primary endpoint indicator. This article discussed how to improve the medication adherence of clomiphene citrate based on PCOSact. We found that 20 (3+15+2) cases were "protocol violation" and there were cases in which researchers made mistakes while distributing medicine and guiding patients how to take medicine. Focusing on these problems we sumed up experience and emphasized the importance of medication compliance through the following aspects:(1) Improvement of insite supervision and remote monitoring; (2) Standardization training for research assistants; (3) Health education for subjects.
