Course Description

This web seminar will explore the evolution of Clinical Data Management from a paper Case Report Form (CRF) process to the “real time” data review capable in the world of electronic data capture (EDC). We will review the specific regulations governing EDC and electronic signature requirements. Participants will examine the changing role of the Clinical Data Manager (CDM) as the technology drives the process, thereby allowing today’s CDM to move forward in the discipline and ensure their place as a viable member of the clinical study team. The EDC technology is enabling the data management component of clinical trial activities to advance and it is important that the CDM is aware of the capabilities the applications have to offer.

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Learning Objectives

• Describe the regulations as they impact data management
• Discuss the rationale and perceived enhancements leading to greater utilization of EDC
• Examine the changing role of the Clinical Data Manager
• Describe the data management documentation required in clinical trial conduct

Who Should Attend

• Clinical Data Managers who are involved in the transition from a paper CRF process to EDC
• Clinical Data Managers new to the EDC process
• Electronic Data Capture Developers who require a better understanding of the CDM process and role

Instructor

The course will be led by one of the following instructors:

Denise G. Redkar-Brown, MT

Click here for complete trainer biographies

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