Shanghai Everbright Convention & Exhibition Center , Shanghai China
Oct 25 2011 7:00AM - Oct 26 2011 3:00PM
Gain Insight into the Quality and Integrity Process of Clinical Data in a GCP Environment. This workshop will provide you with principles and processes involved in the data management life cycle and relationship of data process system with the drug development, including computerized systems, regulatory standards, computerized systems validation, data preparation and submission, as well as how to plan and conduct a data management plan and monitor data integrity and accuracy in the clinical study life cycle. You will also learn the role that clinical data management plays in the eSystem world. FEATURED TOPICS • Regulatory environment and standards and how they relate to data management disciplines • Experiences and roles of clinical data managers • Data management-related challenges/opportunities with new innovative designs in clinical research • Effective communications and interactions between data management professionals and statisticians, programmers, and other clinical professionals • Basic concepts and expectations of data quality and integrity and their improvements governed by GCP standards • Protocol development and CRF design • Best practice in eCRF development and e-systems validation • Document preparation of data management in clinical studies • CSR/CTD completion • Validation of the reliability of medical records in clinical study • E-submission process – from design to implementation • EDC system enhancement and integration Event Code:
11979
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