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Items tagged with CLINICAL TRIALS Files

2001/20/EC Directive

Updated on 18 December 2011

Clinical Trials Directive
Version: 4 April 2001

2004/1031/UK Regulatrion

Updated on 18 December 2011

Statutory instrument 2004:1031 for the UK implementation of the EU clinical Trial directive
Version: 1 May 2004

2005/28/EC Directive

Updated on 18 December 2011

The GCP directive
Version: 8 April 2005

2006/1928/UK Regulation

Updated on 18 December 2011

UK regulatory implementation of the GCP directive 2005
Version: 29 August 2006

21CFR312

Updated on 31 December 2011

Regulation governing human drug research in the USA before marketing approval
Version: Current

75/318/EEC Directive

Updated on 18 December 2011

The first EU directive for control with Clinical Trials
Version: 20 May 1975

Drug Law Germany

Updated on 02 January 2012

German drug law in English
Version: 28 September 2009, note newer updates may be available

Guidance CT3

Updated on 18 December 2011

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)
Version: 11 June 2011

UK guidance for serious breach

Updated on 15 December 2011

Guidance for notification of serious breaches of GCP or the trial protocol

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