Guidance for the notification of serious breaches of GCP or the trial protocol

Table of Contents

Page Number(s):

A. Legal requirement

B. Purpose of the requirement

C Purpose of this guidance

D. Arrangements for notification

E. Identifying serious breaches

F. Potential actions by the MHRA

Appendix I: Notification Examples

Appendix II: Notification Form

Clinical Research News

Nadchodzące badania kliniczne

NCT04607109

Rejestracja na zaproszenie

Long-term Neurodevelopmental Disorders of Prematurely Born Children and Parental Experience

Warunki: Neurodevelopmental Abnormality
NCT04607122

Jeszcze nie rekrutuję

Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery

Warunki: Atrial Fibrillation; Cardiac Surgery
NCT04607135

Jeszcze nie rekrutuję

ARFI Imaging for Targeted Prostate Biopsy

Warunki: Prostate Cancer
NCT04607148

Jeszcze nie rekrutuję

A Study Assessing the Long-Term Safety and Tolerability of RG6147 in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration

Warunki: Macular Degeneration, Age-Related; Geographic Atrophy
NCT04607226

Jeszcze nie rekrutuję

Effects of Respiratory-Gated Transcutaneous Vagal Nerve Stimulation in Major Depression (Phase 1)

Warunki: Major Depressive Disorder
NCT04607252

Jeszcze nie rekrutuję

Metformin Plus Megestrol Acetate as a Fertility-sparing Treatment in Patients With Atypical Endometrial Hyperplasia

Warunki: Atypical Endometrial Hyperplasia
NCT04607317

Jeszcze nie rekrutuję

Exercise as Adjunctive Treatment for Refractory Epilepsy

Warunki: Refractory Epilepsy; Epilepsy
NCT04607343

Jeszcze nie rekrutuję

Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea

Warunki: Obstructive Sleep Apnoea
NCT04607356

Jeszcze nie rekrutuję

Blood Flow Restriction Exercise in the Treatment of Lateral Epicondylalgia Traditional Treatment

Warunki: Tennis Elbow; Lateral Epicondylitis
NCT04607421

Jeszcze nie rekrutuję

BRAF V600E-mutant Colorectal Cancer Study of Encorafenib Taken With Cetuximab Plus or Minus Chemotherapy (BREAKWATER)

Warunki: Neoplasms

Recent CRA jobs