Documents from advisory groups on clinical-trial data

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This page lists the documents from the advisory groups for the policy on proactive publication of clinical-trial data, which met between January and April 2013.

Table of contents


Advisory group on protecting patient confidentiality (CTAG1)

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Advisory group on clinical-trial-data formats (CTAG2)

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Advisory group on rules of engagement (CTAG3)

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Document(s) Language Status First published Last updated Effective Date
CTAG3: Clinical Trial Advisory Group on rules of engagement - Membership overview (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Initial discussion document (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 1.0 – including comments received on this version (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 5.0 – With amendments following comments on 1.0 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 5.0 – Clean version (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 5 March 2013 version 6.0 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.0 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.1 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.2 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 4 April 2013 version 8.0 (English only)   30/04/2013    
CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Final advice 4 April 2013 version 9.0 (English only)   30/04/2013    

Advisory group on good analysis practice (CTAG4)

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Advisory group on legal aspects (CTAG5)

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Document(s) Language Status First published Last updated Effective Date
CTAG5: Clinical Trial Advisory Group on legal aspects - Membership overview (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Initial text (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 1 summary overview (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 2 summary overview (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 1 and 2 comments submitted (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Draft advice (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Draft advice with comments and amendments (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Comments to draft final advice (English only)   30/04/2013    
CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Final advice (English only)   30/04/2013