Delivery Time Frame for the EU Portal and EU Database
- October 2018 – Regulation (EU) No 536/2014 becomes applicable
-
October 2021 – Directive on Clinical Trials 2001/20/EC no longer applicable
These are planned timelines. They have been set out to deliver the clear benefits, for researchers and for patients and the public, that derive from implementation of the Regulation in a timely manner whilst meeting the need for Member States to have available, in the EU Portal and Database, functionality to enable them to commence operation of the Regulation.
The auditable release will contain requirements (auditable and non-auditable) drawn up in collaboration with the Member States and the Commission.
The specifications for the interface between the EU portal and database and workspace and Member States systems will be shared with Member States in mid-2016. The interface itself (Agency system side) will be delivered in Q2 2017.
The specifications for the interface between the EU portal and database and workspace and Member States systems will be shared with Member States in mid-2016. The interface itself (Agency system side) will be delivered in Q2 2017.
The delivery plan is based on an iterative approach with User Acceptance Testing (UAT) of each iteration. Users performing testing will include representative experts from Member States, sponsor organisations and associations representing users of public information – in particular patient and consumer and healthcare professional associations.
The plan and process for UAT will be shared with Member States and the Commission. Member States and the Commission will be involved in the prioritisation of changes to be made based on the results of the UAT, and in particular in the design of and follow-up to the UAT of the auditable release.
Acknowledgement: Colin Wilsher, GCP Consultant (www.theRQA.com)
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The plan and process for UAT will be shared with Member States and the Commission. Member States and the Commission will be involved in the prioritisation of changes to be made based on the results of the UAT, and in particular in the design of and follow-up to the UAT of the auditable release.
Acknowledgement: Colin Wilsher, GCP Consultant (www.theRQA.com)
[Read more…]