Event: DIA China Clinical Data Management Workshop

Dates: October 25 - 26, 2011

Venue: Everbright Int'l Hotel, Shanghai, China

Weblink: www.diahome.org/DIAHome/Education/FindEducationalOffering.aspx?productID=27530&eventType=Meeting

Contact: Mr. Fei Xie

Tel: +86 10 5923 1222, 5923 1288
Email: dia@diachina.org

 

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.

 

 

At the end of the workshop, participants should be able to

 

- Understand the regulations and GCP practices as they impact data management;

 

- Describe in-depth the changing role and challenges of the data manager as well as more efficient
  management and communication of data management in the e-system world;

 

- Outline the DM focus on protocol review and CRF design;

 

- Understand the importance of communication, standardization and documenta­tion in the DM
  prospective;

 

- Learn the "best practice" for DM operation and process;

 

- Identify e-system enhancements and applications in the industry; and

 

- Prepare the participants to contribute positively to a project and implementation of group sequential
  design and analysis (interim analysis).