B. Purpose of the requirement, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA, Medicines & Healthcare products Regulatory Agency

The new requirement was implemented in UK legislation in order to:

1. Enhance the safety of trial subjects/patients by seeking to ensure that the licensing authority is promptly informed of such serious breaches, in order to take appropriate action in response to the breach and/or,

2. To take the information regarding serious breaches into account when assessing future applications for clinical trial authorisation, and applications for marketing authorisation, which include data from trials affected by 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

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
Stroke Care Beyond 4.5 Hours: Trial Tests Simpler CT Screening
Huntington’s Disease: Scientists to Re-Test a Drug Aimed at Preserving Memory and Movement
Blisters, Fever, and Lost Appetite: New Vaccine Against Hand, Foot, and Mouth Disease to Be Tested on 6,000 Children
Helping Your Gut on GLP-1: Can a Daily Fiber Supplement Boost Metabolism During Weight Loss?

Bevorstehende klinische Studien

Clinical Research Jobs

More jobs

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

Abonnieren