Purpose Of This Guidance

C. Purpose of this guidance:

 

  • 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.

 

Clinical Research News

Open Label study of entrectinib in ROS1 gene fusion-positive rare adult, paediatric and teenage/young adult cancers
Gasherbrum Bio, Inc is starting the study of GSBR-1290 drug in overweight or obese healthy adults
A new study of Dexpramipexole in adolescents and adults with severe Eosinophilic Asthma
The study of the DO-2 drug in patients with advanced or refractory solid tumours
Study to compare AT278 with standard insulin aspart NovoRapid® in participants with Type 2 Diabetes
The clinical trial of Quadruple Immunotherapy for Paediatric Patients With Relapsed or Refractory Neuroblastoma
The clinical trial evaluation of the efficacy of HIFU Treatment on Rectal Endometriosis Symptoms (ENDO-HIFU-R2)

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