PNW Chapter: FDA Inspection Readiness: Is Your eSource Fit for Purpose? (ACRP 2025 Conference Replay)
This event will be presenting a replay sessions from the ACRP Conference Library
Event Description:
Join a seasoned U.S. Food and Drug Administration (FDA) Investigator for an overview of how to "stress test" your electronic source (eSource) documents to ensure that they are compliant with FDA regulations and current guidance. This session offers a brief overview of regulatory requirements governing the creation, maintenance, and storage of electronic data at clinical sites and reviews some examples of shortcomings observed in FDA inspections that resulted in FDA Form 483s (Notice of Inspectional Observations) and even Warning Letters. We will also review different types and sources of eSource documentation, including digital health technology, registries used to source real-world data, and electronic medical records, and review common pitfalls associated with them. After the presentation, there will be a live Q&A opportunity.
Speakers:
Barbara D. Wright, FDA Inspector
Learning Objectives:
- Review FDA requirements for electronic records and electronic source data for clinical trial sites
- Define and discuss eSource data in terms of its fitness for purpose
- Discuss what FDA may review during an inspection to assess compliance
Registration & ACRP Contact Hour Information:
- Chapter Member (registration with or without contact hour): $0
- ACRP Member (registration only): $5
- ACRP Member (registration + contact hour): $20
- Non-Member (registration only): $15
- Non-Member (registration + contact hour): $90
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To claim contact hours: Register and purchase the contact hours and attend the event. After attending the event, visit learning.acrpnet.org and log into your ACRP account. Click the “GO TO MY COURSES” box. Find the event in your dashboard, confirm your attendance, and take the event evaluation between 1 and 30 days following the event to obtain the online certificate. After 30 days, contact hours are no longer available.