Bioequivalence and Bioavailability Forum • EU Clinical Trials Register: useless?

EU Clinical Trials Register: useless? [Regulatives / Guidelines]

posted by Helmut – Vienna, Austria, 2018-01-23 14:02 (1889 d 02:57 ago) – Posting: # 18266
Views: 7,966

Hi Beholder,

❝ Saying XML-files, do you mean the special XML "cover" which is used for EU submission (registration dossier)? If so than do you use special software to convert simple pdf to "magic" XML?

Nope. In order to obtain an EudraCT number the sponsor has to create an account / register at the European Clinical Trials Database. The EudraCT number and a completed “Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities and for Opinion of the Ethics Committees in the Community” is required when submitting the protocol to the EMA (CP) or the chosen reference member state (DCP). From the XML a PDF can be created. What is bizarre: The PDF cannot be electronically signed (a signature is required in Section I.3.2). Hence, one has to print it out, sign it, scan the page, …
Once the study is completed, results have to be provided by the same wacky web-interface.

BTW, interesting the EudraCT Statistics as of December 2017 (renumbered):

Number of Clinical Trials recorded in the EudraCT Database: 52,586
Total number of Clinical Trial Applications recorded by Member State, Competent Authorities in the EudraCT Database: 117,198
Total number of Clinical Trial Site Inspections: 6,734
Total number of EudraCT Numbers requested in response to the question: “Is it anticipated that this EudraCT Number will be used for a Clinical Trial conducted in a third country (outside of the EU/EEA)?”: 0

#2 is higher than #1 since “a clinical trial may involve several Member States. Each Member State creates a record; therefore several records may exist for one clinical trial representing each of the Member States involved. The total given here represents the number of individual Member State records of clinical trials and is therefore higher than the number of separate trials provided under #1 above.”
#3: 12.8% of studies were inspected? Wow! Given that some studies with an assigned EudraCT number were never performed, the percentage is higher.
#4: Zero?!

—
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Helmut Schütz

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Complete thread:

BE studies register in EU Beholder 2018-01-19 11:56 [Regulatives / Guidelines]
- BE studies register in EU Ohlbe 2018-01-19 12:01
  - BA studies register in EU Helmut 2018-01-19 12:32
  - BE studies register in EU Beholder 2018-01-19 13:10
    - BE studies register in EU nobody 2018-01-19 15:03
      - EU Clinical Trials Register: useless? Helmut 2018-01-22 15:47
        
        EU Clinical Trials Register: useless? nobody 2018-01-22 16:20
        
        these days only? Beholder 2018-01-23 08:09
        
        EU Clinical Trials Register: useless? Beholder 2018-01-23 08:15
        
        EU Clinical Trials Register: useless?Helmut 2018-01-23 13:02
        
        EU Clinical Trials Register: useless? Ohlbe 2018-01-23 17:54
        
        EU Clinical Trials Register: useless? Helmut 2018-01-23 17:57
        
        EU Clinical Trials Register: useless? Ohlbe 2018-01-24 11:48
        
        Studies outside the EU/EAA: Zero? Helmut 2018-01-24 12:12
        
        Studies outside the EU/EAA: Zero? ElMaestro 2018-01-24 13:15
        
        Data base corrupted? Helmut 2018-01-24 22:51