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.
Clinical Research News
Upcoming Clinical Research Training and Conferences
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on demandACROSS Global Training AcademyOnline
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Upcoming Clinical Trials
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Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruiting
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National Taiwan University HospitalNational Taiwan University Hospital Bei-Hu BranchRecruitingSuccessful CannulationTaiwan
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University of British ColumbiaMcMaster UniversityNot yet recruiting
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The Affiliated Nanjing Drum Tower Hospital of Nanjing...RecruitingPrimary Aldosteronism | Mineralocorticoid Receptor Antagonist | FinerenoneChina
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Zoya Haitov Ben ZikriRecruitingWisdom Teeth Extraction or Jaw ImplantIsrael
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Cairo UniversityRecruiting
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AstraZenecaMerck Sharp & Dohme LLCRecruitingMetastatic Castration-resistant Prostate CancerGermany
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University Hospital, MotolNot yet recruitingType 1 Diabetes Mellitus | Type 1 Diabetes Mellitus With Hypoglycemia | Drive
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University of LouisvilleNot yet recruitingMyocardial InjuryUnited States
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University of MiamiRecruiting
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University of ConnecticutYale UniversityNot yet recruiting
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Pamukkale UniversityNot yet recruitingPremenstrual Syndrome | Laughter