Data Management: Key Regulations Impacting the Role of the Clinical Data Manager January 2016

Jan 12, 2016
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Course Description

In conducting clinical research, there are some specific regulations that directly impact the discipline of Clinical Data Management (CDM). 21 CFR Part 11 includes mandatory regulations that govern clinical trials data. It requires a system in which electronic records and signatures are trustworthy, reliable, and secure; electronic signatures that are equivalent to paper records and handwritten signatures executed on paper; a system that discerns invalid or altered records; and signatures that are linked to an electronic record. The “Guidance for Industry—Computerized Systems Used in Clinical Trials,” builds on the importance of information inclusion when utilizing computerized systems. In addition, the recently finalized “Guidance for Industry: Oversight of Clinical Investigations—A Risk-Based Approach to Monitoring” specifically mentions the role that Clinical Data Management is expected to have in assisting in a risk-based monitoring approach. In this web seminar, we will explore the information in these regulations/guidances that will further the understanding of their impact on our current way of working.

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Learning Objectives

  • Define the 21 CFR Part 11 regulations as they impact Clinical Data Management
  • Describe what is meant by an electronic signature
  • List components defining “computerized systems”
  • Identify the Clinical Data Manager’s role in risk-based monitoring

Who Should Attend

  • Clinical Data Managers
  • Clinical Research Professionals


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

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.