Virtual | Virtual
Event Title
Electronic Systems, Electronic Records, and Electronic Signatures Webinar
April 25, 2023
- Date:
- April 25, 2023
- Time:
- 3:00 PM - 4:30 PM ET
|
Topic & Presentations |
Speakers |
|---|---|
|
Electronic Systems, Electronic Records, and Electronic Signatures Webinar |
|
|
Introduction |
Leonard Sacks, MBBCh |
|
Overview of Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers |
Elizabeth Kunkoski, MS |
|
Regulatory Expectations regarding 21 CFR 11 during GCP inspections |
Kassa Ayalew, MD, MPH |
|
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 (e.g., 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
- Guidance for Industry Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers (March 2023)
- Guidance for Industry Part 11, Electronic Records; Electronic Signatures - Scope and Application (August 2003)
- Guidance for Industry Electronic Source Data in Clinical Investigations (September 2013)
- Draft Guidance for Industry, Investigators, and Other Stakeholders Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (December 2021)
Event Materials
| Title | File Type/Size |
|---|---|
| Electronic Systems, Electronic Records, and Electronic Signatures Webinar_April_25_2023.pdf | pdf (962.21 KB) |