Safety Reporting
Current section refers to the item 4.11 Safety Reporting of the INTEGRATED ADDENDUM TO ICH E6(R1): GUIDELINE FOR GOOD CLINICAL PRACTICE E6(R2). It provides an overview of requirements for reporting of Serious Adverse Events occurring during a clinical trial.
4.11.1 All serious adverse events (SAEs) should be reported immediately to the sponsor except for those SAEs that the protocol or other document (e.g., Investigator's Brochure) identifies as not needing immediate reporting. The immediate reports should be followed promptly by detailed, written reports.
The immediate and follow-up reports should identify subjects by unique code numbers assigned to the trial subjects rather than by the subjects' names, personal identification numbers, and/or addresses.
The investigator should also comply with the applicable regulatory requirement(s) related to the reporting of unexpected serious adverse drug reactions to the regulatory authority(ies) and the IRB/IEC.
4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.
4.11.3 For reported deaths, the investigator should supply the sponsor and the IRB/IEC with any additional requested information (e.g., autopsy reports and terminal medical reports).
Clinical Research News
Предстоящие клинические испытания
-
University of TennesseeWoodcock Institute for the Advancement of Neurocognitive Research and Applied PracticeЕще не набираютДвигательные навыки | Здоровый | Исполнительная функция
-
University of Texas Southwestern Medical CenterMerck Sharp & Dohme LLCЕще не набираютАнальная плоскоклеточная карцинома
-
Universita di VeronaAzienda Ospedaliera Universitaria Integrata VeronaЕще не набираютРевматоидный артрит | Дегенеративное заболевание коленного суставаИталия
-
University of Wisconsin, MadisonAlkermes, Inc.Еще не набирают
-
Virginia Commonwealth UniversityЕще не набираютОтек мозга | Радиационный некрозСоединенные Штаты
-
Weill Medical College of Cornell UniversityNational Institute of Mental Health (NIMH); Icahn School of Medicine at Mount SinaiЕще не набираютКетамин | фМРТ | Депрессия - Большое депрессивное расстройство | рТМС | Резистентная к лечению депрессия (TRD)Соединенные Штаты
-
Weill Medical College of Cornell UniversityBD2 LLCЕще не набираютфМРТ | Биполярное расстройство (БД) | рТМС | Биполярная депрессия 1Соединенные Штаты
-
Xentria, Inc.Еще не набирают
-
Yale UniversityNational Institute of Mental Health (NIMH)Еще не набирают
-
Cambridge University Hospitals NHS Foundation TrustUniversity of CambridgeРекрутингФеохромоцитома | Феохромоцитома/параганглиома | Феохромоцитома, Метастатическая | Феохромоцитома злокачественная | Феохромоцитома и параганглиома (PPGL)Соединенное Королевство
-
Carl Zeiss Meditec-Dublin CoCeРекрутингЭпиретинальная мембрана | Болезнь сетчатки | Дегенерация желтого пятна, связанная с сухим возрастом | Витреоретинальная аномалия | Macular Abnormalities | Intraretinal Hyporeflective Space | Subretinal Hyporeflective Space | IS/OS (Ellipsoid Zone) Disruption | Retinal Pigment Epithelium (RPE) Elevation и другие заболеванияСоединенные Штаты
-
Celest Therapeutics (Shanghai) Co., Ltd.The First Affiliated Hospital of Anhui Medical UniversityРекрутингCLDN18.2 Положительные солидные опухолиКитай
Clinical Research Jobs
-
Czechia - Brno
-
Belgium - Leuven
-
United Kingdom - Tranent
-
Romania - Bucharest
-
United StatesCanada - Québec - Quebec
-
United Kingdom - Guildford
-
India - Bengaluru
-
United States - North Carolina - Morrisville
-
China
