0. EU Portal and Database project
19 October 2017
Agenda item 04.0
EU Portal and Database project
Status Update
EU clinical trials portal and Union database stakeholders meeting
Presented by Wim Nuyts on 24 February 2016
Project Manager – IT Delivery

1. 19 October 2017
Overview
The Management Board, at its December 2015 meeting, has endorsed the timeframe for the implementation of the EU clinical trial portal and database. The Board emphasised that it is of critical importance that the EU system provides the required functionalities to all stakeholders in the most efficient and stable way from the start of its operation. The timeframe foresees that the database and portal are available for independent audit by August If the system gets a green light from the audit, the EU Clinical Trial Regulation will come into effect by October 2018 at the latest. The Agency is revising the development plan on this basis. The planning revision is expected to lead to some changes in the schedule of functionality across the iterations.
The first development iteration has been completed and its output, Release 0.1, is undergoing formal (“SAT”) testing at EMA.
Release 0.1 covers an initial, partial implementation of the functionality to prepare and submit an Initial CTA, and of the MS process to appoint the RMS.
In addition, a User Interface/Experience concept has been developed and implemented in Release 0.1.
Release 0.1 will be provided for User Acceptance Testing (UAT) in March.
EU Portal and Database project - Status Update - 24 February 2016

2. EU portal and database - Maximum project timeline
19 October 2017
EU portal and database - Maximum project timeline
EU Portal and Database project - Status Update - 24 February 2016

3. Use Case review schedule - Release 0.2ID
Title
Release
TC dates*
Offline circulation dates
SUBGROUP
Subgroup review
SUC1022
Prepare & submit response to RFI
Release 0.2
04-Feb-16
SG1
TC - sponsor
SUC1021
Consolidate considerations and request information
26-Feb-16
SG2
TC - Member states
SUC1020
Validate CTA
25-Feb-16
Offline - Member states
SUC1008
Complete trial details
01-Mar-16
SUC1026
Assess Part I
30-Mar-16
SUC1029
Submit decision
23-Mar-16
SUC1013
Withdraw application
Offline - sponsor
SUC1028
Assess Part II
05-Apr-16
SUC1025
View trial summary
19-Apr-16
* Any changes to the teleconference dates will be communicated by the Agency.
EU Portal and Database project - Status Update - 23 February 2016

4. Member States & Stakeholder
High-level UAT 1 process
Build
Test
Comms
UAT
Env. Prep
&
Data Prep
2 days
Conduct EMA UAT dry-run (“pre-UAT”) to validate test scripts and environment setup 10 days
UAT Execution
5 days for UAT 1
Consolidation of UAT feedback and reporting
5 days
Pre-UAT
2.5 weeks
3 weeks for UAT 1
Plan and coordinate UAT (incl. development of UAT scenarios, scripts and communications with participants)
Plan UAT
Up to 6 weeks
Member States & Stakeholder
EU Portal and Database project - Status Update - 24 February 2016

5. Key UAT 1 meetings and dates
Milestone
Date
Description
UAT focal points deadline
15th January 2016
Deadline for Organisations and Member States to provide the EMA with a nomination for their UAT focal point.
All UAT tester deadline
31st January 2016
Deadline for Organisations and Member States' UAT focal point to provide the EMA with details of all testers.
UAT 101 webinar
11th February 2016
Webinar to introduce UAT concepts.
Pre-UAT 1 start
19th February 2016
EMA UAT testing commences.
UAT 1 pr ing
25th February 2016
Specific UAT 1 preparatory information shared with UAT focal points via .
UAT 1 kick-off webinar
10th March 2016
Provision of final test scripts for UAT 1 and UAT logistics overview.
UAT 1 execution start
11th March 2016
Member States receive system access to complete UAT 1.
Iteration 1 demonstration webinar
Webinar to give overview of the functionality developed in iteration 1.
UAT 1 execution end
17th March 2016
Deadline for testing and UAT focal points to provide consolidated feedback to the Agency.
UAT 1 feedback provided
29th March 2016
Provision of UAT 1 feedback by the Agency to the UAT focal points.
EU Portal and Database project - Status Update - 24 February 2016