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Thread: The EU Clinical Trials Regulations 2016 - implentation in the UK?

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  1. #1
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    Hi Shahnaz,

    I am particularly interested in this implementation date and have searched for any updates and thought that you might find the following of interest:

    There is a link on the EMA website to the following document:
    Functional specifications for the EU portal and EU database to be audited: (http://www.ema.europa.eu/docs/en_GB/...C500179339.pdf)

    This gives some details of what the portal would do and the underlying database that will be used for clinical trials. It is 16 pages long and is not grippingly exciting stuff as it just describes the elements of functionality that must be included by law. This was signed off in April 2015.

    There is a working group: “clinical trials information system expert group” and the only update or status report available gives the following:

    1. EU PORTAL AND EU DATABASE

    1.1. EMA process and milestones
    The EMA is currently drafting the detailed rules and criteria on what data and documents are to be made public, i.e. the draft appendix on data transparency to the “functional specifications for the EU portal and database to be audited”. The draft appendix will be submitted for endorsement to the EMA Management Board in October 2015. For this purpose, the EMA is consulting the European Commission, the Member States and organised separate stakeholder meetings for the pharmaceutical industry, academic researchers, healthcare professionals and patient organisations in June (see section1.2).
    The overall final timeline regarding the design and development of the EU portal and the EU database will be announced by the EMA by “mid 2015”. The EMA team responsible for building the IT system and infrastructure for the EU portal and the EU database is being set up and will start working with full capacity in the fourth quarter of 2015. It is expected that it will take around 10 months from the point when the system is ready for audit until the Clinical Trials Regulation (CTR) applies. It is therefore likely that the CTR will not apply before the second quarter of 2017.

    So, given the complexities of the database/portal and the inclusion of all the national authorities requirements etc. the 2nd quarter of 2017 might even be optimistic.

    Gordon
    Attached Thumbnails Attached Thumbnails Click image for larger version. 

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  2. #2
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    Thank you all for the replies posted here, very informative

    Best wishes

    Shahnaz

  3. #3
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    Hi Shanaz, Here is an update in case you haven't seen it about the timelines for implementation of the EU CTR 536/2014, plannedfor October 2018, pending audting of the EU database and portal.

    http://www.ema.europa.eu/docs/en_GB/...C500199078.pdf

    I attach a screenshot, but if you can't see it clearly, it is within the pdf document in the link above.

    Best regards,
    Fiona
    Click image for larger version. 

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  4. #4
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    You should remember that the EMA said that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".
    The EU clinical trials portal and Union database stakeholders meeting (08Dec2015) their plan, stated (information issued 15 Dec 2015), that the regulation would apply from 4Q 2017.

    So the timeline of Oct 2018 is a maximum, but the people working on the portal think that the Regulation may apply from 4Q2017. Be prepared!

  5. #5
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    The EU clinical trials portal and Union database stakeholders meeting (Feb 2016) has now updated their timeline and it is the same as the EMA document - regulation applies Oct 2018. But it should still be remembered that :- "This is a maximum timeline and every effort will be made to bring the Regulation into application as soon as possible....progress of implementation of the system will be closely monitored ...and hence application of the Regulation to an earlier time as possible".

  6. #6
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    Of course the story still continues! In October 2019 the EMA posted:--

    Update: In October 2019, EMA's Management Board endorsed the six-monthly monitoring report on the development of the CTIS, which assesses the performance of the IT supplier against agreed key performance indicators. The Board agreed that actions proposed in the report should be further developed, for example improving the quality of the work delivered by the supplier and selecting the critical items needed for audit, as well as extending the monitoring period for at least three releases.
    The product owners validated the first release developed in the agile, iterative delivery in September 2019, confirming that all 79 items had been delivered.
    The release enhanced CTIS functionalities for the submission of clinical trials and the assessment process, user management and included other general improvements.
    The product owners will begin to carry out an operational assessment of the system to identify critical business blockers, in order to enable EMA's Management Board to consider the timing of the audit of the system.

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