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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on demandACROSS Global Training AcademyOnline
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Upcoming Clinical Trials
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Tongji HospitalNot yet recruitingPostoperative Analgesia
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Sohag UniversityNot yet recruiting
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Sound Biopharmaceuticals Ltd.Recruiting
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University of BariDoctors with Africa - CUAMMNot yet recruitingTuberculosis, Pulmonary
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Assistance Publique - Hôpitaux de ParisInstitut Curie; Centre National de la Recherche Scientifique, France; Collège...Not yet recruiting
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Tianjin Medical University Cancer Institute and...Not yet recruitingPancreatic CancerChina
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University of PennsylvaniaEunice Kennedy Shriver National Institute of Child Health and Human Development...Not yet recruitingPre-Eclampsia | Pregnancy LossUnited States
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The First Affiliated Hospital of Xinxiang Medical...Not yet recruitingCardiovascular Diseases | Vascular Diseases | Cancer | Cardiac Diseases
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University Health Network, TorontoNot yet recruitingPost-Operative Prostate Cancer
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University Hospital Bispebjerg and FrederiksbergRecruitingActivities of Daily Living | Muscle Strength | Disability Evaluation | Surveys and Questionnaires | Health Status | Physical Examination | ADL Motor SkillsDenmark
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The First Affiliated Hospital with Nanjing Medical...Not yet recruiting
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Dhulikhel HospitalNot yet recruitingPostnatal CareNepal