GUIDANCE Superseded

Guidance for Records Related to Clinical Trials

HC · 2020 Health Canada

ABSTRACT — EDITORS' SUMMARY

Health Canada guidance on essential-document creation, maintenance, and retention for clinical trials conducted under Division 5 of the Food and Drug Regulations. Includes Q&A-style content on record-keeping duration, remote / electronic records, sponsor vs investigator custody, and inspection-time production expectations.

LIVE SOURCE · CONTINUOUSLY UPDATED

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METADATA

TypeGUIDANCE

Year2020

VersionCurrent

StatusSuperseded

FormatHTML

Pages—

Size—

Last reviewedJAN 2020

SOURCE

HTML · CANONICAL LINK https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/guidance-records-related-clinical-trials.html ↗

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