Documents from advisory groups on clinical-trial data

HumanRegulatory and procedural guidanceClinical trialsData on medicines

Estonian is available via eTranslation, the European Commission's machine translation service.

Translate to Estonian | Important information about machine translation

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

English (EN) (90.62 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (30.6 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (305.59 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (110.9 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (124.89 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (201.83 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (50.87 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

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

English (EN) (101.11 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (25.27 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (264.22 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (239.04 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (92.65 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (136.64 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (74.16 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

Advisory group on rules of engagement (CTAG3)

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

English (EN) (105.46 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (122.33 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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 (EN) (271.44 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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 (EN) (87.6 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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 (EN) (76.8 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (265.14 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (123.95 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (164.83 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (111.29 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (123.88 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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 (EN) (118.2 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

Advisory group on good analysis practice (CTAG4)

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

English (EN) (91.92 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (45.39 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (438.6 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (364.51 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (157.88 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (81.73 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (59.12 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (57.52 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (66.63 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (224.3 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (340.54 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (424.82 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (226.15 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

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

English (EN) (347.99 KB - PDF)

Esmakordselt avaldatud: Viimati ajakohastatud:
Vaata

Share this page