Electronic Systems, Electronic Records, and Electronic Signatures Webinar – 04/25/2023

Electronic Systems, Electronic Records, and Electronic Signatures Webinar – 04/25/2023

Topics & Presentations

Speakers

Electronic Systems, Electronic Records, and Electronic Signatures Webinar

Introduction

Leonard Sacks, MBBCh
Associate Director
Clinical Methodologies
Office of Medical Policy (OMP) | CDER | FDA

Overview of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers

Elizabeth Kunkoski, MS
Health Science Policy Analyst
Clinical Methodologies
OMP | CDER | FDA

Regulatory Expectations regarding 21 CFR 11 during GCP inspections

Kassa Ayalew, MD, MPH
Director
Division of Clinical Compliance Evaluation
Office of Scientific Investigation | CDER | FDA

Q&A Discussion Panel

Same as above

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ABOUT THIS WEBINAR

As technology advances, the electronic data flow between systems is more efficient and more prevalent. Understanding the evolving uses of electronic records, electronic systems, and electronic signatures in clinical investigations is important. 21 CFR 11 helps ensure the authenticity, integrity, and reliability of data submitted in support of marketing applications or submissions. In this webinar, FDA will present the current thinking regarding 21 CFR 11 and its application to electronic records, electronic systems and electronic signatures during a clinical investigation.

TOPICS COVERED

  • Overview of 21 CFR 11
    • Scope and application
    • Rationale for part 11
  • Electronic records in a clinical investigation
    • Data sources
    • Certified copies
    • Retention and transmission of electronic records
  • Electronic systems
    • Validation
    • Security safeguards
    • Audit trails
  • Information technology service providers
  • Digital health technologies and data
  • Electronic signatures

FDA SPEAKERS AND PANELISTS

Introduction
Leonard Sacks, MBBCh

Associate Director
Clinical Methodologies | Office of Medical Policy (OMP) | CDER | FDA

Overview of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
Elizabeth Kunkoski, MS

Health Science Policy Analyst
Clinical Methodologies | OMP | CDER | FDA

Regulatory Expectations regarding 21 CFR 11 during GCP inspections
Kassa Ayalew, MD, MPH

Director
Division of Clinical Compliance Evaluation | Office of Scientific Investigation | CDER | FDA

INTENDED AUDIENCE

  • Regulatory science and regulatory affairs professionals working on clinical investigations (eg, IND, IDE, INAD)
  • Researchers working on electronic systems that store data for clinical investigations
  • Consultants focused on electronic records, electronic systems and electronic signatures for clinical investigations (21 CFR 11)
  • Developers or vendors of electronic systems that produce records for clinical investigations
  • Developers or vendors of electronic signature services that work with stakeholders involved in clinical investigations

FDA RESOURCES

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