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.
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Upcoming Clinical Trials
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RobotDreams GmbHRecruitingAngina Pectoris | Acute Coronary Syndrome | NSTEMI - Non-ST Segment Elevation MI | STEMI - ST Elevation Myocardial InfarctionAustria
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Xinhua Hospital, Shanghai Jiao Tong University...RecruitingArtificial Intelligence | Diagnosis | Congenital Heart Disease in Children | Deep Learning | ElectrocardiogramChina
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Synergy Spine SolutionsMCRANot yet recruitingCervical Degenerative Disc DiseaseUnited Kingdom
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University of MichiganAtriCure, Inc.Not yet recruitingPain, Postoperative | Intrathoracic ProcedureUnited States
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University of ExeterAdvanced Growers Limited; Ecog Pro LimitedRecruitingInflammationUnited Kingdom
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China-Japan Friendship HospitalRecruitingChronic Kidney Diseases | Lipid Metabolism Disorders | Coronary Heart DiseaseChina
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Institute of Mental Health, SingaporeNational University of SingaporeNot yet recruiting
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Fangbiao TaoNot yet recruitingPerinatal Depression | Stepped Care
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Pusan National University Yangsan HospitalNot yet recruitingGynecological Surgery