C. Purpose of this Guidance, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA

  • To outline the practical arrangements for notification.
  • To provide advice on what should and what should not be classified as a “serious breach” and what must be reported.
  • To outline possible actions that may be taken by the MHRA in response to notifications of serious breaches.

Back to the index of the Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA, Medicines & Healthcare products Regulatory Agency

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