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  1. Review of substantial amendments by competent authority delayed

    The CCMO as competent authority currently has a delay in reviewing substantial amendments.

    News item | 22-07-2019 | 09:55

  2. Changes regarding submission of clinical trial agreement

    From today, the signed version of the clinical trial agreement (CTA) may be submitted to the review committee (accredited MREC or ...

    News item | 21-05-2019 | 13:29

  3. Template subject information from 1 April 2019 criterion for review of information letter

    The Template subject information, which helps researchers to write a concise and clear information letter for research subjects, ...

    News item | 31-01-2019 | 09:44

  4. Template for annual safety report of investigator-initiated research with a medicinal product

    In response to an initiative of UMC Utrecht, the CCMO has made a template available for the annual safety report for ...

    News item | 31-01-2019 | 09:26

  5. Examples of subject information letters available

    To help investigators write a short and clear subject information letter, the CCMO published two examples of subject information ...

    News item | 14-01-2019 | 16:22

  6. CCMO launches a new website

    On 5 November 2018 the CCMO launched a new version of its corporate website

    News item | 05-11-2018 | 00:00

  7. EU clinical trial portal expected to go live in 2020

    The EU portal and database for clinical trials are expected to go live in 2020. This was announced by the European Medicines ...

    News item | 08-10-2018 | 13:03

  8. Change in procedure competent authority

    As competent authority, the CCMO has the task to check the European adverse reactions database, EudraVigilance, for suspected ...

    News item | 28-09-2018 | 15:07

  9. Informed Consent Form template updated in line with GDPR

    The template for the Informed Consent Form has been updated. The immediate cause for this is the amendment of the General Data ...

    News item | 09-05-2018 | 11:23

  10. Answers to frequently asked questions about the European Clinical Trial Regulation

    News item | 24-04-2018 | 10:11