Gefragt von: Annika Harris
Fragesteller Allgemeines

Eu Clinical Trials Portal

Der Link der Eu Clinical Trials Portal-Seite ist unten angegeben. Seiten, die sich auf Eu Clinical Trials Portal beziehen, werden ebenfalls aufgelistet.

Zuletzt aktualisiert: 2021-04-21

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Added by: Suman Desu

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Clinical trials | Public Health

Transition from the Clinical Trials Directive to Regulation. Until the Clinical Trials Regulation EU No 536/2014 will become applicable, all clinical trials performed in the European Union are required to be conducted in accordance with the Clinical Trials Directive. This Directive will be repealed on the day of entry into application of the Clinical Trials Regulation.
Url: https://ec.europa.eu/health/human-use/clinical-trials_en
Clinical trials | Public Health

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Clinical Trial Regulation | European Medicines …

The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). CTIS will contain the centralised EU portal and database ...
Url: https://www.ema.europa.eu/en/human-regulatory/research-development/clinical-trials/clinical-trial-regulation
Clinical Trial Regulation | European Medicines …

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Informed consent for paediatric clinical trials in Europe

For clinical trials with an IMP: AMG §42 applies. Legal age of consent is 18. One parent has to sign ("Erziehungsberechtigter"). For clinical trials with an MD: MPG §51 applies. Legal age of consent is 18. One parent has to sign ("Erziehungsberechtigt er").
Url: https://www.ema.europa.eu/en/documents/other/informed-consent-paediatric-clinical-trials-europe-2015_en.pdf
Informed consent for paediatric clinical trials in Europe

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Home - ClinicalTrials.gov

ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Explore 374,155 research studies in all 50 states and in 220 countries. See listed clinical studies related to the coronavirus disease (COVID-19) ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. IMPORTANT ...
Url: https://clinicaltrials.gov/
Home - ClinicalTrials.gov

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EudraCT

EudraCT is a database of all clinical trials which commenced in the Community from 1 May 2004, and also includes clinical trials linked to European paediatric drug development. The following tasks can be performed from this page: Create a EudraCT number. Before any functionality of EudraCT can be used for a given clinical trial, a EudraCT number must be created in order to provide a unique ...
Url: https://eudract.ema.europa.eu/results-web/
EudraCT

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Listing of Clinical Trial Registries | HHS.gov

May 28, 2015. The International Committee of Medical Journal Editors announced a policy in 2004 that as a condition of publication, clinical trials would be required to be listed in a public registry .Subsequently, regulatory authorities around the world began to require the posting of clinical trial information and, in some cases, the submission of summary results to a publicly accessible ...
Url: https://www.hhs.gov/ohrp/international/clinical-trial-registries/index.html
Listing of Clinical Trial Registries | HHS.gov

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Clinical Trials & Studies - Bristol-Myers Squibb

Clinical trials and research are a critical part of bringing new medicines to patients. Through the data generated from clinical trials, we answer important scientific questions and gain a better understanding about the efficacy and safety of these study medicines and …
Url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Clinical Trials & Studies - Bristol-Myers Squibb

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GSK - CSHD (Clinical Support Help Desk)

GSK Study Portal (GSP) A single web-based source of information for all GSK clinical studies (drug trials) pulling together information from various source systems (such as eTrack) into one place. Electronic Document Exchange (eDX) A global web based application to enable the management and processing of electronic documents associated with execution of clinical studies. ClinicalTrials.gov ...
Url: http://www.clinicalsupporthd.gsk.com/
GSK - CSHD (Clinical Support Help Desk)

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New EU Clinical Trials Regulation: What’s New?

New EU Clinical Trials Regulation: What’s New?

Added by: MHRAgovuk

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EU Exit and post-transition guidance, clinical trials webinar - October 2020

EU Exit and post-transition guidance, clinical trials webinar - October 2020

Added by: European Medicines Agency

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Clinical Trials in the EU

Clinical Trials in the EU

Added by: European Medicines Agency

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Module 05 - Clinical trials in the EU

Module 05 - Clinical trials in the EU

Added by: European Medicines Agency

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Implementation of the clinical trials regulation

Implementation of the clinical trials regulation

Added by: European Medicines Agency

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Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA)

Accelerating clinical trials in the EU (ACT-EU) by I. Den Rooijen (EMA)

Added by: Blog de la recherche clinique

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New European Union regulation on clinical trials of drugs - Applicable on 31 January 2022

New European Union regulation on clinical trials of drugs - Applicable on 31 January 2022

Added by: European Medicines Agency

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Clinical Trials in the EU - MT version

Clinical Trials in the EU - MT version

Added by: GCP-Mindset - All About Clinical Research

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Clinical Trials in Central Europe

Clinical Trials in Central Europe

Added by: European Medicines Agency

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Clinical Trials Information System Demonstration for CTIS stakeholders – part 1

Clinical Trials Information System Demonstration for CTIS stakeholders – part 1
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