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
-
on demandACROSS Global Training AcademyOnline
-
29 September 2023 – 02 October 2024SCDM (Society of Clinical Data Management)United States
-
21 – 23 May 2024InformaBelgium
-
03 – 04 June 2024The Society for Clinical Research Sites (SCRS)United States
-
16 – 17 July 2024The Society for Clinical Research Sites (SCRS)Australia
-
27 September – 29 October 2024The Society for Clinical Research Sites (SCRS)United States
Prossimi studi clinici
-
RobotDreams GmbHReclutamentoAngina pectoris | Sindrome coronarica acuta | NSTEMI - MI con elevazione del segmento non ST | STEMI - Infarto del miocardio con sopraslivellamento del tratto STAustria
-
Xinhua Hospital, Shanghai Jiao Tong University...ReclutamentoIntelligenza artificiale | Diagnosi | Malattie cardiache congenite nei bambini | Apprendimento approfondito | ElettrocardiogrammaCina
-
Synergy Spine SolutionsMCRANon ancora reclutamentoMalattia degenerativa del disco cervicaleRegno Unito
-
Minnesota HealthSolutionsNon ancora reclutamentoProblemi di sicurezza | Infortunio al veicolo a motoreStati Uniti
-
University of MichiganAtriCure, Inc.Non ancora reclutamentoDolore, Postoperatorio | Procedura intratoracicaStati Uniti
-
University of ExeterAdvanced Growers Limited; Ecog Pro LimitedReclutamentoInfiammazioneRegno Unito
-
Universiteit LeidenUniversity of AmsterdamNon ancora reclutamento
-
China-Japan Friendship HospitalReclutamentoMalattie renali croniche | Disturbi del metabolismo lipidico | Malattia coronaricaCina
-
Institute of Mental Health, SingaporeNational University of SingaporeNon ancora reclutamento
-
Northwestern UniversityReclutamentoStenosi ureteraleStati Uniti
-
Fangbiao TaoNon ancora reclutamentoDepressione perinatale | Cura a gradini
-
Pusan National University Yangsan HospitalNon ancora reclutamentoChirurgia Ginecologica