Clinical trial governance

Se ha producido un error en la entrega o similar, y necesita ser arreglado por el equipo de

Dear European Medicines Agency,

This FOI request is being filed on behalf of TranspariMED.

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:

1. A list of all paediatric clinical trials registered on EudraCT as of 01 May 2020 that had been completed six or more months previously and for which no summary results had been uploaded by the sponsor as of 01 May 2020. Please provide this data ***in Excel format***, including the following columns: (a) trial ID number, and (b) name or acronym or country of the NCA responsible for the trial. If possible (optional), please also include additional columns with (c) the name of the trial's sponsor and (d) the trial's name/title.

2. According to the Minutes of the Meeting of the Expert Group on Clinical Trials held 22 November 2019, "A short video was presented by EMA to demonstrate the current status of the CTIS providing details on the workspaces to authorities and sponsors."
Please provide a copy of that video.

Note: I am aware that EMA already attempted to release a copy of the video to Mr Jaume Vidal in response to his FOI request filed on 11 March 2020:
However, instead of providing the video, EMA provided him with a two page PDF document. Please ensure that this time the full video is shared. EMA could consider uploading the video to its website or a third party platform, and then in response to this FOI request share the link to the video rather than the video file itself, provided that the video is publicly available (i.e. is accessible without login or password requirements).

Postal address: Till Bruckner, c/o BIH QUEST Center, Anna-Louisa-Karsch-Str. 2, 10178 Berlin, Germany

Yours faithfully,

Till Bruckner

Agencia Europea de Medicamentos

2 Adjuntos

Delivery has failed to these recipients or groups:

[1]documents requests at EMA ([EMA request email])
The email address you entered couldn't be found. Please check the
recipient's email address and try to resend the message. If the problem
continues, please contact your helpdesk.

Diagnostic information for administrators:

Generating server:

[EMA request email]
Remote Server returned '550 5.1.1 RESOLVER.ADR.RecipNotFound; not found'

Original message headers:

Received: from ( by
( with Microsoft SMTP Server (TLS) id 15.0.1497.2; Wed, 27 May
2020 19:04:45 +0200
Received: from ( by ( with Microsoft SMTP Server (TLS) id
15.0.1497.2 via Frontend Transport; Wed, 27 May 2020 19:04:45 +0200
Return-Path: <[FOI #7995 email]>
Received: from [] (using TLSv1.2 with cipher DHE-RSA-AES256-GCM-SHA384 (256 bits))
by id 30/31-52160-CAD9ECE5; Wed, 27 May 2020 17:04:44 +0000
Authentication-Results:; spf=none (spf record not
found); dkim=none (message not signed);
dmarc=none (no record)
X-Brightmail-Tracker: H4sIAAAAAAAAA+NgFupikeJIrShJLcpLzFFi42LR01bP0V0z91y
X-Env-Sender: [FOI #7995 email]
X-Originating-IP: []
X-SpamReason: No, hits=0.0 required=7.0 tests=newsletters:
X-StarScan-Version: 9.50.1; banners=-,-,-
X-VirusChecked: Checked
Received: (qmail 12566 invoked from network); 27 May 2020 17:04:44 -0000
Received: from (HELO (
by with ECDHE-RSA-AES256-GCM-SHA384 encrypted SMTP; 27 May 2020 17:04:44 -0000
Received: from foieu by with local (Exim 4.89)
(envelope-from <[FOI #7995 email]>)
id 1jdzTv-0007KO-7z
for [EMA request email]; Wed, 27 May 2020 18:04:43 +0100
Date: Wed, 27 May 2020 18:04:43 +0100
From: Till Bruckner <[FOI #7995 email]>
To: documents requests at EMA <[EMA request email]>
Message-ID: <[email address]>
Subject: access to documents request - Clinical trial governance
MIME-Version: 1.0
Content-Type: text/plain; charset="UTF-8"
Content-Transfer-Encoding: 7bit


Visible links
1. mailto:[EMA request email]