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Introduction to Data Management December 2010

Course Description

This course provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and to other individuals who wish to learn basic clinical data management skills and the functions.

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Learning Objectives

  • Identify the roles and responsibilities of the clinical data management (CDM) research team
  • Discuss the protocol design and development process and data management
  • Recognize the CDM start-up activities/documentation
  • Discuss case report form design, data tracking and collection, data entry and capture
  • Discuss data review, validation, and queries
  • Recognize the rationale of the MedDRA dictionary
  • Discuss database lock and release
  • Examine adverse event reporting and reconciliation
  • Apply suggestions for future study

Who Should Attend

  • Sponsor/CRO staff whose function is to review, correct, enter, or manage data, with less than one year of experience
  • Individuals who desire a basic understanding of the function of clinical data management

Instructor 

Denise G. Redkar-Brown

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Course Length Time

3 hours; 12:30 - 3:30 p.m. Eastern

Course Dates 

December 9, 2010

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2012 Good Clinical Practice Question & Answer Guide Electronic Edition 

CFR/ICH GCP Reference Guide 2012 (Spiral Bound) 

CFR/ICH GCP Reference Guide 2012 (Perfect Bound) 

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