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European Clinical Trials Directive

Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

Informed consent for clinical trials in acute coronary syndromes and stroke following the European Clinical Trials Directive: investigators' experiences and attitudes

... and clinical efficacy and safety to be approved for general use. Clinical research nowadays is governed by widely accepted strict ethical and quality standards, based on the Declaration of Helsinki [1] and ...

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Pan-European Clinical Trials (ECT) – Final Report

Pan-European Clinical Trials (ECT) – Final Report

... ongoing clinical trial that features an unprecedented multinational research collabora- tion aimed at improving the treatment strategy of a rare malignant disease affecting children and young adults by means of an ...

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Proposal for a revision of the "Clinical Trials Directive" (2001/20/EC) and other recommendations to facilitate clinical trials

Proposal for a revision of the "Clinical Trials Directive" (2001/20/EC) and other recommendations to facilitate clinical trials

... The European Union Directive 2001/20/EC (CTD) was adopted in 2001 to regulate clinical trials in ...of clinical research, and facilitate transnational clinical tri- ...conducting ...

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Input analysis for two public consultations on the EU Clinical Trials Regulation

Input analysis for two public consultations on the EU Clinical Trials Regulation

... Good Clinical Practice were not applied consistently throughout the ...for trials, including risk–benefit analysis, data protection issues, informed consent, reporting of suspected adverse reactions, ...the ...

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Research ethics committees: agents of research policy?

Research ethics committees: agents of research policy?

... the European Union's directive for good clinical trials further differentiates drug ...that clinical trials are lesser in the interest of patients and society than routine health ...

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Characteristics of clinical trial websites: information distribution between ClinicalTrials gov and 13 primary registries in the WHO registry network

Characteristics of clinical trial websites: information distribution between ClinicalTrials gov and 13 primary registries in the WHO registry network

... about clinical trials is not easily accessible by the ...Japan, clinical trial information can be accessed by the general public through online registries; however, many people find these registries ...

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Workshop report on the 2nd Joint ENCCA/EuroSARC European bone sarcoma network meeting: integration of clinical trials with tumour biology

Workshop report on the 2nd Joint ENCCA/EuroSARC European bone sarcoma network meeting: integration of clinical trials with tumour biology

... Matthew Sydes presented the first results of the EURAMOS-1 (NCT00134030). Good Response (GR) randomization, assessing pegylated interferon-α2b (ifnα). Of 2.260 registered patients, 1.041 had a known GR and 715 of these ...

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Open access clinical trial registries: the Italian scenario

Open access clinical trial registries: the Italian scenario

... public clinical trials registry (CTR) ...four European countries (France, Italy, United Kingdom and Spain) has been guaranteed by the DEC-net registry (Drug Evaluation in Children - the ...

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Access to Personal Data in Social Networks : measuring the effectiveness of approaches to regulation (Transfer report)

Access to Personal Data in Social Networks : measuring the effectiveness of approaches to regulation (Transfer report)

... on European Union 1992 treaty and the earlier EC Accession Treaty signed by the United Kingdom in January 1972 ...as European Law originating from the European ...the European Union 2007 ...

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Proposal for a Directive of the European Parliament and of the Council amending Directive 95/2/EC on food additives other than colours and sweeteners (presented by the Commission). COM (99) 329 final/2, 18 November 1999

Proposal for a Directive of the European Parliament and of the Council amending Directive 95/2/EC on food additives other than colours and sweeteners (presented by the Commission). COM (99) 329 final/2, 18 November 1999

... Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption 1 , as amended by ...

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The establishment of the European Asylum Support Office and its impact on EU asylum policy

The establishment of the European Asylum Support Office and its impact on EU asylum policy

... 17 Commission Communication towards a common asylum procedure and a uniform status, valid throughout the Union, for persons granted asylum, COM(2000) 755, Part 2.1; dividing the development in a short term establishment ...

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Proposal for a Council Directive amending Directive 91/439/EEC on driving licenses. COM (95) 166 final, 10 May 1995

Proposal for a Council Directive amending Directive 91/439/EEC on driving licenses. COM (95) 166 final, 10 May 1995

... Draft Proposal for a Council Directive amending Directive 91/439/EEC on driving licences THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Communit[r] ...

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Options for reforming deposit protection schemes in the EU  ECRI Policy Brief No  4, March 2011

Options for reforming deposit protection schemes in the EU ECRI Policy Brief No 4, March 2011

... In order to ensure that depositors are reimbursed quickly, the Commission proposes to reduce the time delay for payout to one week. The 1994 Directive envisaged a reimbursement period of three months with a ...

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Clinical Trials

Clinical Trials

... Clin ical trials are closely supervised by appropriate regulatory authorities. All studies that involve a medical or therapeutic intervention on patients must be approved by a supervising ethics committee before ...

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1689th Meeting of the Council (Environment). Council Press Release 8906/93 (Presse 155), Luxembourg, 5 October 1993

1689th Meeting of the Council (Environment). Council Press Release 8906/93 (Presse 155), Luxembourg, 5 October 1993

... 5.X.93 AMENDMENT OF THE DIRECTIVE ON HAZARDOUS WASTE Pending the Opinion of the European Parliament, the Council discussed the proposal for a Directive amending Directive 91/689/EEC on h[r] ...

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Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

Sponsorship in non-commercial clinical trials: definitions, challenges and the role of Good Clinical Practices guidelines

... covered the different aspects of trial initiation and man- agement [18]. The recent new Guidelines, issued in July 2014 [19], do not include anymore a formal definition of sponsor; however, the sponsor is still held ...

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