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

Clinical Research News

Il primo vaccino progettato dall'IA completa la sperimentazione umana
Blood in Urine and Suspected Tumor: New Urine Test to be Compared Against Cystoscopy and Biopsy
When Ultrasound Shows an Anomaly but Genetics Are Silent: Whole-Genome Gequencing (WGS) Put to the Test
Chronic Pancreatitis and Cancer Risk: Scientists Look to the Immune System for Early Clues
Protecting the Heart Before Going Home: Hospitals Test Giving Flu Shots Right Before Discharge
High Cholesterol: New Non-Statin Drug to Be Compared Directly With Bempedoic Acid
Delivering Radiation Straight to the Tumor: New Prostate Cancer Trial Begins

Prossimi studi clinici

Clinical Research Jobs

More jobs

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

Sottoscrivi