Considerations for Using eTools in Research: Part 11 & System Validation

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Technology is advancing all around us. Traditional paper-based processes are rapidly being replaced with a proliferation of electronic tools to capture and automate clinical research activity. Automation is a foregone conclusion, and research sites need to prepare themselves for the electronic future that lies ahead.

Topics

  • US and international regulations
  • Part 11 and Annex 11: two parts, records, and signatures
  • Validating your system
  • Division of responsibility

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Presented by Advarra

Advarra provides institutional review board (IRB), institutional biosafety committee (IBC) and global research compliance services to clinical trial sponsors, CROs, hospital systems, academic medical centers and investigators. Its robust regulatory expertise and innovative technology ensure the highest standards of research review are met, while putting participants first and meeting complex human research protection oversight requirements.