PDF《临床质量保证培训课程》

4 07:30 C 08:30 REGISTRATION 08:30 C 09:30 SESSION 1: OVERVIEW OF ICH-E6 GCP: A FOUNDATION OF GOOD CLINICAL QUALITY SYSTEM Introduce basic elements and standards of IEH E6 GCP, helping trainees understand the foundation of a clinical quality system and becoming familiar with the GCP standards and responsibilities applied in the clinical trials. 09:30 C 10:45 SESSION 2: FUNDAMENTALS OF QUALITY COMPLIANCE OF CLINICAL TRIALS: QC/QA ELEMENTS AND QMS Describe the definitions and difference of quality control from quality as- surance. Outline the importance of quality and establishment of clinical quality system into the clinical trial procedures and activities. Moreover, overview basic principles of clinical data global data quality and integrity applied in clinical studies and discuss the relationship of data quality to date integrity in the full life c........