Electronic Data Integrity in a GxP Environment: Managing the Data Lifecycle for Compliance
Instructor:
Sarah Fowler Dixon
Product ID: 705451
Training Level: Intermediate to Advanced
- Duration: 60 Min
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
Sarah Fowler-Dixon
Education Specialist, Washington University
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.
More Training By Experts
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- What are Serious Adverse Events and How do I Handle These?
- New Part 11 Guidance for Clinical Trials: What This Means for You
- Institutional Review Boards (IRBs): The Changing Landscape and the Effect on the Conduct of Clinical Research
- Achieving Research Compliance Through Risk Assessment
Refund Policy
Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).
