A. Legal Requirement, Guidance for the Notification of Serious Breaches of GCP or the Trial Protocol Version 6, 08 Jul 2020, MHRA

Regulation 29A of the Medicines for Human Use (Clinical Trials) Regulations 2004 [Statutory Instrument 2004/1031], as amended by Statutory Instrument 2006/1928, contains a requirement for the notification of “serious breaches” of GCP or the trial protocol:

“29A. (1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of –

(a) the conditions and principles of GCP in connection with that trial; or

(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25, within 7 days of becoming aware of that breach.

(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree –

(a) the safety or physical or mental integrity of the subjects of the trial; or

(b) the scientific value of the trial”.

 

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

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?
Heart Attack and Stroke Risks Can Develop for Years: Sweden to Test Home Screening Kits
Preventive Cancer Vaccine to Be Tested in People with Lynch Syndrome
Type 1 Diabetes Can Develop Silently: New Screening Method to Be Tested During Routine Pediatric Visits
Pancreatic Cancer Is Often Caught Too Late: Japan to Test a New Blood Screening Method

Bevorstehende klinische Studien

Clinical Research Jobs

More jobs

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

Abonnieren