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Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle...

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Description

This webinar will provide an understanding of the data integrity and data lifecycle within the GxP environment. Attendees will learn best practices to comply with the current regulations and industry standards for electronic data integrity throughout the data lifecycle.

Why Should You Attend:

FDA regulations 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The sponsor may select but additional source document procedures are required at the investigator site. Three FDA mandated inspectional criteria: origination, authorization, and signature are need for a compliant data capture process.

Not using a compliant system will create non-compliance findings. Knowing what the federal regulations require will avoid non-compliance and help you set up a compliant system.

Areas Covered in the Webinar:

  • FDA definitions for data elements
  • FDA definitions of source data and types of electronic source data systems
  • The requirement for original source data to support every data element
  • The requirements for electronic data-origination, authorization, signatures and data tracking
  • What types of electronic data elements pose non-compliance challenges
  • Preventing non-compliance by sponsor due diligence at investigator site
  • Participant input and questions

Who Will Benefit:

  • Clinical Research Coordinators and Investigators
  • Medical Record Personnel
  • Clinical CRA Monitors
  • Clinical Program Managers
  • Clinical Quality Assurance Auditors

Instructor Profile:

Dr. Sarah Fowler-Dixon, PhD, CIP is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects’ research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research management to graduate and undergraduate students. More recently, she led a task force in the development of the Community Engaged Research Program at Washington University.

Dr. Fowler-Dixon has simultaneously served as an Independent Consultant, providing expertise and creating supplemental educational materials, including a copyrighted workbook. Prior to joining Washington University, she was the Educational Development and Learning Specialist for Saint Louis University serving on various committees to improve research, procedures, community outreach, and retention.

Note: Use coupon code REFERRAL10 and get 10% off on registration.

For Registration:

http://www.complianceonline.com/electronic-data-integrity-in-a-gxp-environment-webinar-training-705451-prdw?channel=eventbrite

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