Electronic Source Documents in Clinical Trials: Complying with FDA

Event Information
Product Format
Prerecorded Event
90 Minutes
Product Description

Know All That You Need to Know About FDA’s Guidance on Electronic Source Documents

With the prevalence of electronic health records (EHR) and electronic data capture (EDC), the use of electronic source documentation is increasingly common. However, there is a wide-spread lack of awareness about FDA’s requirements for measures to ensure integrity of the systems used to generate and retain electronic source data.

Join Dr. Mukesh Kumar in this power packed session to discuss the FDA’s guidance regarding the use of electronic source documentation, providing direction to sponsors, project managers, data management centers, and clinical site staff on capturing, using, and archiving electronic data in FDA regulated clinical trials. He’ll also discuss the identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the EDC, and Investigator responsibilities with respect to reviewing and retaining electronic data. Also, he’ll use case studies to highlight common issues and potential solutions with using electronic source documents and comparing them to paper documents.

Dr. Kumar will list the key elements of an FDA compliant system for generating and maintaining electronic source documents. Best practices for creating and maintaining auditable documents will also be discussed with case studies.

Session Highlights

  • FDA’s guidance on electronic source documents
  • Best practices for data entry, data review, and data processing and transmission
  • Training requirements for site staff in data origination, integrity, review, and release for processing and retention
  • Best practices for documentation practices and policy
  • Audit trails and auditing practices for electronic source data verification

Who Should Attend?

  • Clinical Research Associates
  • Project Managers
  • Clinical Research Associate Managers
  • Clinical Investigators and Staff
  • Quality Assurance and Compliance Professionals
  • Data Management Professionals
  • People investing in FDA-regulated products intended for the US market

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About Our Speaker

Dr. Mukesh Kumar - Pharma Regulation Expert

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...   More Info
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