All the work related the clinical trial should be strictly limited to the stipulation of GCP and based on the regulation of the medicine and drug management.

Professional team is responsible for the monitoring and operating the clinical trial. Before the clinical trial, according to the principal of GCP and the drug Standard Operating Procedure (SOP), the team should establish precise Protocol, Investigators Brochure, CRF and other relevant documents, train the investigators for Good Clinical Practice (GCP), and assess them. In the clinical trial process, the team should regularly or irregularly visit the study site, fill out the Monitoring Report Form, and report to the sponsor. The team should also guide the investigators to correctly collect data, to fill out the CRF truly and completely, to review the quality of the trial, and to push forward the clinical trial. Meanwhile, the team should properly settle the unexpected problems in the process and make necessary supplement and revision, to ensure that all the data could be recorded correctly and put into the database timely. After the clinical trial, the team should analyze the statistic data and make the conclusion on the clinical trial, which will provide completed and reliable reference for the clinical trial report.