Abstract: Standard Operating Procedures (SOP)of clinical investigators are established according to SFDA ,ICH and WHO Good Clinical Practice standards, and experiences of clinical trials practice in our hospital.It includes qualification and competence of investigators, prior to initiation of the study, screening and recruitment of study subjects, obtain informed consent from all trial subjects, protocol compliance, provide medical care for trial subjects, randomization procedures and unblinding, safety reporting, source data document, case report forms, product management, premature termination or suspension of a trial, progress and final reports, and investigator’sfiles.

Key words: institution of clinical trial, investigator, Standard Operating Procedures(SOP), source document, case report forms