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ICH E6(R3) guide for research sites: an inspection readiness test, plus how Moffitt cut missing training attestations 86% with a connected eISF workflow.

Connectivity Has Become a Compliance Requirement

Walk into your next monitoring visit with the evidence already on file.

Most of the work before a monitoring visit or inspection is assembling, by hand and study by study, evidence that a connected workflow would already show. This guide sets out what E6(R3) expects of investigators and how connected centres answer inspector questions without reconstructing events from email chains and spreadsheets.

What you’ll learn:

  • What a compliant answer to each inspector question requires, and which of that evidence a connected site already holds.
  • How to document the rationale behind the level of oversight your investigator applies to delegated tasks.
  • Why the workflows that shorten study startup are often the same ones that improve inspection readiness.
  • A five-question self-check your team can run before the next monitor arrives.