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Understanding and Implementing Clinical Data Management in EDC Trials

Sep 15 2014 7:00AM - Sep 16 2014 3:00PM | Xinjiang Plaza Attn: Miss Ying Zhao No. 7 Sanlihe Road 100027 Beijing China

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Overview 

Computerized systems and electronic data management have been embedded into clinical research at a rapid pace, in all kinds of applications. Therefore, it is essential that what follows is an in-depth understanding that covers all aspects of computerized systems used in clinical research, and establishing project QMS and documented evidence that provides a high degree of assurance that a clinical trial with EDC supports will consistently produce a product meeting its pre-determined specifications and quality attributes. This workshop will outline the basic principles and applications of computerized system design, testing, implementation and regulations, regardless of the type of computers or equipment being used in clinical research. Also, this workshop is to establish proven methodologies of applications and managements to make certain a computerized system is properly planned, implemented and evaluated, thus ensuring the quality and integrity of data collected by sponsors for evaluating a drug’s safety and efficacy in the electronic clinical environment. Moreover, the clinical data programming that supports CDM in the compliance with CDISC standard will be addressed.

Who Should Attend 

  • Data Management Professionals
  • Clinical Project Management
  • Clinical Study Professionals
  • Clinical Investigators and Coordinators
  • Clinical Monitors
  • Biostatisticians
  • Clinical data Programmers
  • Clinical quality assurance and quality control professionals
  • E-clinical computer system users
  • Professionals of Clinical Quality Control and Assurance

Learning Objectives 

  • Overview the e-clinical regulatory environment, standards, and how it relates to the DM disciplines
  • Understand EDC study implementation and major features and methodologies of EDC systems used in clinical studies
  • Describe the good practice of electronic clinical system used and challenge in e-clinical trials
  • Learn importance and methodology of clinical system validation and maintenance
  • Define experiences and roles of clinical data managers and DM related challenges/opportunities in the e-clinical environment
  • Outline best practice in eCRF development and e-system validation
  • Explore the relations of SAS programming supporting CDM to CDISC standards in e-clinical studies
  • Introduce EDC system enhancement and integration

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

To Register, click here.

Registration Fees 

Member

Charitable Nonprofit/Academia Member
¥2000.00
Member Government
¥2000.00
Member Standard
¥2500.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥2800.00
NonMember Government
¥2800.00
NonMember Standard
¥3300.00
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