Guidance for the notification of serious breaches of GCP or the trial protocol
Table of Contents
Page Number(s):
D. Arrangements for notification
E. Identifying serious breaches
F. Potential actions by the MHRA
Appendix I: Notification Examples
Appendix II: Notification Form
Latest trials
-
NCT04465201Not yet recruitingConditions: Cardiac Output
-
NCT04465214Not yet recruitingConditions: Neoplasms; Solid Tumors; Prostate Cancer; Lung Cancer; Colon Cancer
-
NCT04465227Not yet recruitingConditions: Hypoparathyroidism
-
NCT04465240Not yet recruitingConditions: Residential Characteristics; Emotions; Stress, Psychological; Stress, Physiological
-
NCT04465253RecruitingConditions: Breast Carcinoma; Lymphedema
-
NCT04465266RecruitingConditions: Healthy
-
NCT04465279CompletedConditions: Refractive Errors
-
NCT04465292Not yet recruitingConditions: Pemphigoid, Bullous
-
NCT04465305RecruitingA Randomized Controlled Study on the Treatment of Sacral Canal Cysts With Sacral Canal ReinforcementConditions: Tarlov Cysts
-
NCT04465318Not yet recruitingConditions: COPD
Featured Contract Research Organizations
-
AlphaGenesis Incorporated (AGI)
AGI has enjoyed tremendous success and growth throughout the years, and as we have grown, we have strengthened our dedication to providing only the be...
-
Scientist
By enabling scientists to easily Outsource Everything But the GeniusTM, we are pioneering a faster, leaner and more innovation-centric approach to res...
-
Cmed
Cmed specializes in complex disease areas, particularly oncology, immuno-oncology, cell therapy and other specialty therapeutics areas.Clinical trials...
-
Hurley Consulting
Hurley Consulting Associates Ltd. is an international consulting company serving the health sciences industry since 1987. With unique expertise to pr...