Documents from advisory groups on clinical-trial data

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.

Advisory group on protecting patient confidentiality (CTAG1)

CTAG1: Clinical Trial Advisory Group on protecting patient confidentiality - Membership overview

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Discussion Document

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after first teleconference

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after first teleconference with comments

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after second teleconference with comments

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Revised after third teleconference with comments

CTAG1: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on protecting patient confidentiality - Final advice

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

CTAG2: Clinical Trial Advisory Group on clinical-trial-data formats - Membership overview

CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats – Initial text

CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats - meeting 1 outcome with comments

CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats - meeting 2 outcome with comments and amendments

CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats – meeting 3 outcome with comments and amendments

CTAG2: Advice to the European Medicines Agency on Clinical Trial Advisory Group on clinical-trial-data formats - Final draft advice outcome with comments

CTAG2: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on clinical-trial-data formats - Final advice

Advisory group on rules of engagement (CTAG3)

CTAG3: Clinical Trial Advisory Group on rules of engagement - Membership overview

CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Initial discussion document

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

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

CTAG3: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on rules of engagement - Draft advice version 5.0 – Clean version

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 5 March 2013 version 6.0

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.0

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.1

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 22 March 2013 version 7.2

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Draft 4 April 2013 version 8.0

CTAG3: Advice to the European Medicines Agency on rules of engagement for accessing clinical-trial data - Final advice 4 April 2013 version 9.0

Advisory group on good analysis practice (CTAG4)

CTAG4: Clinical Trial Advisory Group on good analysis practice - Membership overview

CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - Discussion document

CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - First draft with comments

CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - Second draft and comments

CTAG4: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on good analysis practice - Final advice

Advisory group on legal aspects (CTAG5)

CTAG5: Clinical Trial Advisory Group on legal aspects - Membership overview

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Initial text

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 1 summary overview

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 2 summary overview

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Meeting 1 and 2 comments submitted

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Draft advice

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Draft advice with comments and amendments

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Comments to draft final advice

CTAG5: Advice to the European Medicines Agency from the Clinical Trial Advisory Group on legal aspects - Final advice