GUIDANCE
Notification of Serious Breaches of GCP or the Trial Protocol
ABSTRACT — EDITORS' SUMMARY
Sponsor obligation and process for notifying MHRA of serious breaches. Threshold definitions, notification timing, content requirements.
LIVE SOURCE · CONTINUOUSLY UPDATED
Read live on www.gov.uk ↗ METADATA
SOURCE
HTML · CANONICAL LINK https://www.gov.uk/government/publications/clinical-trials-for-medicines-notification-of-serious-breaches-of-gcp-or-the-trial-protocol ↗ RELATED · SAME AUTHORITY