Clinical trial governance

Till Bruckner made this Informationsfreiheit request to Europäische Arzneimittel-Agentur

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Dear European Medicines Agency,

This FOI request is being filed on behalf of TranspariMED.
www.TranspariMED.org

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."
https://ec.europa.eu/transparency/regexp...
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:
https://www.asktheeu.org/en/request/info...
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

Europäische Arzneimittel-Agentur

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