Communication from the Commission regarding the guideline on the data fields contained in the clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004
Date: 2008-07-03
Institutions: European Commission
Subjects: access to information, database, medical research, medicinal product, public health, testing

3.7.2008

EN

Official Journal of the European Union

C 168/3

Communication from the Commission regarding the guideline on the data fields contained in the
clinical trials database provided for in Article 11 of Directive 2001/20/EC to be included in the
database on medicinal products provided for in Article 57 of Regulation (EC) No 726/2004

(2008/C 168/02)

1. INTRODUCTION

Article 57 of Regulation (EC) No 726/2004 (1) provides for the
European Medicines Agency to establish a database on medicinal
products authorised in the Community to be accessible to the
general public — the so-called EudraPharm database (2). This
provision also stipulates that, where appropriate, the database
shall also include references to data on clinical trials currently
being carried out or already completed, contained in the clinical
in Article 11 of Directive
trials database provided for
2001/20/EC (3) — the so-called EudraCT database (4).

The same provision requires that the Commission issues guide-
lines on the clinical trials data fields which could be included
and which may be accessible to the public, by identifying the
data fields from the clinical trials database corresponding to the
information that may be included in EudraPharm.

This information is of potential value to patients, their carers
and the health professions, who have a potential
interest in
ongoing or completed trials. At the same time, more transparent
further
information can contribute to the development of
research helping to ensure that better
trials are designed,
requiring fewer patients and avoiding unnecessary duplication.
The pharmaceutical industry, academia and the scientific com-
munity and regulators are other potential users of this type of
information.

The EudraCT database includes clinical
trials on medicinal
products for human use, with at least one site in the Com-
munity, and which commenced in at least one Member State
following the transposition of Directive 2001/20/EC. Clinical
trials commencing prior to that point and clinical trials with no
site in the Community are not included in EudraCT and cannot
those
therefore be referenced by EudraPharm (except
third country paediatric clinical trials that are included in a
Paediatric Investigation Plan in accordance with Regulation (EC)
No 1901/2006. Publication of information on paediatric clinical
trials is to be the subject of a separate guideline).

for

The purpose of this guideline is to identify the data elements
from the EudraCT database corresponding to the information to
be included in EudraPharm, to identify the trials which will be
included and to set out the criteria for the update of this data.
The overall purpose is to provide relevant information to the
public in the interests of public health.

At the time of publication of this guideline the EudraCT data
fields are for the most part consistent with international initia-
tives relating to clinical trial registries, e.g. WHO International
Clinical Trials Registry Platform (ICTRP) and the International

(1) OJ L 136, 30.4.2004, p. 1.
(2) http://eudrapharm.eu
(3) OJ L 121, 1.5.2001, p. 34.
(4) http://eudract.emea.europa.eu

Journal Editors

(ICMJE). Although
Committee of Medical
EudraCT may have additional fields, the convergence of the
information to be made public with the WHO ICTRP facilitates
the work of sponsors and researchers submitting information to
different registries for different purposes, and facilitates the
access of patients, health professionals and citizens in general to
this information.

2. DEFINITIONS

Applicable definitions will be those contained in Directive
2001/83/EC and Directive 2001/20/EC.

3. SCOPE

Taking into consideration that the EudraCT database is only
accessible to the competent authorities of the Member States
and the European Medicines Agency in order to ensure that the
confidentiality of the data is strictly observed and to protect the
legitimate interests of sponsors, the information to be made
publicly available keeps the balance between this principle and
the need to inform the public in the interests of public health
and transparency.

With these objectives in mind the information to be made avail-
able needs to be meaningful for the public, also by following
agreed standards at international level. Moreover, phase I trials,
certain details of
the investigational
the characterisation of
medicinal products, certain details of the clinical trial design,
information on batch release aspects, legal status of the sponsor,
trial sites and any personal related information are
clinical
excluded from publication.

The information referred to in Section 4 to be included in the
EudraPharm database shall cover clinical trials of phases II, III
and IV, regardless of whether the medicinal product concerned
has already received a marketing authorisation in the Com-
munity or not.

Each clinical trial will be listed as ‘ongoing’ or ‘ended’. This
status will be listed for each Member State with the relevant
dates.

Clinical trials which have received a decision from the Compe-
tent Authority and/or a favourable opinion from the Ethics
Committee, in the Member State in question, will be identified
in the EudraPharm database. Once the clinical trial has been
approved it will be listed as ‘ongoing’. This listing will change to
‘ended’ once the clinical trial has been registered as ended in
EudraCT.

C 168/4

EN

Official Journal of the European Union

3.7.2008

4. INFORMATION ELEMENTS TO BE INCLUDED IN THE

EUDRAPHARM DATABASE

The information to be published in the EudraPharm database
will consist of data fields on the clinical trial
including the
following elements:

(a) Identification of the clinical trial and the sponsor:

— EudraCT number for the clinical trial,

(d) General descriptive information on the clinical trial and the

patient population included:

— major objective,

— principal inclusion and exclusion criteria of the clinical

trial,

— phase of the clinical trial,

— design (e.g. randomised, controlled),

— sponsor's designation and protocol code number,

— comparators (medicines/other treatments) if this is part

— full title of the trial,

— the International Randomised Standard Clinical Trial

Number (IRSCTN) where available in EudraCT,

— other international identifier(s) to be defined,

— contact point(s) for further information.

(b) Identification of the medicinal product:

The medicinal product will be identified by as much of the
following that is available in EudraCT (the nature of the clin-
ical trial may mean that some items are not present in
EudraCT):

— name of the medicinal product,

— active substance(s),

— route of administration,

— therapeutic classification code,

— appropriate international identifiers.

(c) Identification of the indication under study in the clinical

trial and of orphan designation:

The indication(s) will be described in accordance with the
agreed international terminology at the level used in the
clinical trial application.

Where a product has been designated as an orphan medic-
inal product for the indication under study this will be indi-
cated and the designation number provided.

of the clinical trial,

— number of patients anticipated in the clinical trial,

— age range(s),

— gender.

Taking in consideration the ongoing developments of
the
EudraCT database, as a result of international convergence and
the implementation of Regulation (EC) No 1901/2006, publica-
tion of clinical trial results, both positive and negative, will be
included as the information becomes available on the database
and will need to be provided in accordance with the guidance
on the clinical trial application form and the declaration of the
end of a clinical
form, as published by DG ENTR in
Volume 10 of EudraLex (1).

trial

5. GUIDANCE ON IMPLEMENTATION

A glossary will be provided in an appropriate location on the
database website, explaining the relevant technical and regula-
tory terms and acronyms for the benefit of the general public.

DG Enterprise and Industry will publish detailed data elements
corresponding to the information that is to be included in
EudraPharm.

The actual physical and logical data models to be used in imple-
menting this guideline will be drawn up through object model-
ling. Other functionalities will have to be defined by technical
specifications to be prepared when this guideline is imple-
mented.

(1) http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/homev10.htm