Course Description

This web seminar provides an excellent introduction to clinical research data management, focusing on processes and their rationale, making it ideal for the new data manager and other individuals who wish to learn basic clinical data management 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 with less than one year of experience and whose function is to review, correct, enter, or manage data
• Individuals who desire a basic understanding of the function of clinical data management

Instructor

Denise G. Redkar-Brown, MT

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.