Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
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3rd Annual Clinical Trials Quality & Compliance
13-14 September 2018
Updates on the new
EU Clinical Trial Portal
Dr. Stefano Marini
EUCROF Vice-President European Contract Research Organization Federation
13-14 September 2018
European CROs Federation
EUCROF - Status September 2018
• EUCROF is a non-profit organisation founded on 2005
• Members are registered legal entities :
• Associations of CROs, or
• Private companies working in Clinical Research Support
National Member Associations Country N. CROs
1. ACRO-CZ Czech Republic 18 Associate Members
2. ACRON The Netherlands 45 1. Albania
3. AECIC Spain 28 2. Austria
4. AFCROs France 70 3. Bulgaria
4. Denmark
5. AICRO Italy 23 5. Germany
6. ASCRO Sweden 13 6. Portugal
7. BeCRO Belgium 29 7. Serbia
8. Switzerland
8. BVMA Germany 42
9. Ukraine
9. CCRA United Kingdom 36 10. United Kingdom
10. HACRO Greece 10
11.SAKDER Turkey 26 Partner Members
12. SACROP Slovakia 21 1. Algeria
2. Israel
3. Lebanon
TOTAL: >352 Companies, 23 Countries , over 23.000 employees
2
EUCROF September – 2018 Geographic Representativeness EUCROF Members & Associates EUCROF Partners Relationship in development
Number of Clinical Studies in EU
Eudract Eudract Numbers issued in EU
YEAR Numbers 7.000
issued in EU 6.000
5.000
4.000
2011 6.011 Eudract Numbers issued
3.000
in EU
2012 5.399 2.000
1.000
2013 5.406 0
2014 5.549
2015 5.526
2016 5.144
Nov 2017 4.742*
Aug 2018 3.309
* Data on Dec 2017 not available
4
Clinical Trials Migration
5
European Commission Intent in 2012
6
…. And that’s the outcome……
7EU Clinical Trial Portal definition
• The portal and database is the most ambitious IT development project so far required
by the EU pharmaceutical legislation.
• The objective is one over-arching IT system that can connect the various systems in
place in the Member States and enables them to talk to each other. It requires
different types of access and actions depending on the user (MSs (NCAs/Ethics
committees), sponsors (industry/academia), general public).
• Given that every new clinical trial in the EU will have to pass through the portal and
database, it is essential that the system is fit for purpose from day one to fulfil the
goals of the Clinical trial Regulation.
• EMA, the Commission , the Member States and Sponsor representatives carried out
intensive testing on an intermediate release (0.6) of the system during UAT in
November 2017
8What should the Agency deliver?
• Single EU entry point for clinical trial applications
• Collaboration in the evaluation and supervision at EU level
EU PORTAL • Provides workspace collaboration tools, workflow and
AND
DATABASE document management capabilities
(Art 80-84)
• Provides publicly available information
• Delivers a module for the electronic reporting of suspected
SAFETY
unexpected serious adverse reactions (SUSARs)
REPORTING
• Delivers an electronic reporting system for annual safety
(Art. 40 and 44)
reports (ASRs)
EUDRACT
LEGACY
• Delivers transition between the current and new systems
(Art 98)
9 Implementation of the new Clinical Trial Regulation (EU) No 536/2014 - EMA perspectiveCollaborative working
The EMA is working collaboratively
Presented by Anabela Marcal
Head of Committees and Inspections Department
European Medicines Agency
EUROPEAN
EUROPEAN MEDICINES
COMMISSION AGENCY
STAKEHOLDERS
MEMBER STATES - Sponsors
& ETHICS - CROs
COMMITEES - Health Care Professionals
- Patient Representatives
to develop systems to implement the regulation
10 EU Portal and Database UpdateEU portal and database – High Level System Overview (2/2)
CT Portal/
EU DB
Sponsors NCAs and Ethics Committees EC EMA MA Applicant Public
Open
Secure Access
Access
Business
Create
Application
Evaluate
Application
Supervise
CT
Manage
Reports
Submit CSR Disseminat
e CT Info
Processes
Issue Submit Manage Manage Access CT
Notification Results Users Publication Info
Sponsors Authority
System
Workspace Interfaces
Workspace
BI Reports UI Public Website
CT
Industry Authority Business CT Public
System System Intelligence Register
Systems
Sponsor’s Workflow MS
Interface Engine Interface
CT DB Public DB
11 EU Portal and Database UpdateEU portal and database – System Interfaces
MSs
Sponsors
CT Portal/EU DB
WHO
Business
EMA Processes
System
Interfaces
User Master Data
Registration Management
& Security (RMS/OMS)
(IAM)
CT
Systems
CT DB Public DB
Data Document
Warehouse Management EV Human
12 (DWH) (DMS)Sponsor Workspace Overview -Key Features for Sponsors
Confidential work area where Sponsors can prepare and compile data and information to
Sponsors
Workspace
submit via the EU portal to the EU database as well as access already submitted data for
their Trials.
• Search for trials I have access to • View detailed application dossier (data
• Trials current status overview and documents)
My CTs • Access CT Application Dossier CT • Manage my Trial (Complete application
Overview & Application dossier for new / updated trial, issue
• Submit new Applications
Search Dossier Notifications etc)
• Download data and documents
• See formal or informal requests for • Invite users to access trials
information from Member States and
My • Assign roles to users for trials
respond
Requests for User
• See deadlines for responses • 2 different approaches: Organisation
Information Management
• Prepare responses to RFI Centric vs CT centric
• See all alerts and notices for all my trials • Imports CT Applications, Notifications and
My • Get reminders for important deadlines Trial Results to the Sponsor Workspace
Notices & Sponsors
Alerts Interface
13 EU Portal and Database UpdateActions by the user Left inside Right inside navigation navigation
What the public sees
17How to search in the database
Ricerca
avanzata
18Results of the search
19Introduction to User Acceptance Testing (UAT)
What is User Acceptance Testing (UAT)?
• UAT is the validation of business functions and the system flow against business
requirements
• UAT is carried out by end users of the system
• Other types of testing are carried out prior to UAT. These verify that the
functionality and features of the system conform to the documented requirements
• UAT is planned to be carried out every three months within the CT programme
UAT verifies the system has the right features
Other test types verify the system has no significant bugs
20UAT66Summary
UAT Update (1/2)
UAT 6 – Recap and participation
The key focus of on-site testing was the interaction between sponsors and member states as part of specific
end-to-end scenarios. For example, a pair of sponsor delegates worked together to create, populate and
submit a clinical trial application which was then assessed by a corresponding pair of member state testers.
For off-site testing, test scenarios and support materials were provided to the focal point of each
organisation. Focal points then co-ordinated testing and testers within their respective organisations.
On-site Participation
• A total of 35 individual testers executed on-site testing at the EMA facilities;
- 15 of these testers were representatives from across 8 different sponsor organisations.
- 20 of these testers were delegates from across 20 different member states.
Off-site Participation
• A total of 8 sponsor organisations submitted feedback for off-site sponsor test scenarios.
• A total of 14 member states submitted feedback for off-site member state test scenarios.
• The European Commission (EC) also completed the off-site member state test scenarios.
UAT update Feb-2018UAT66Summary
UAT Update (1/2)
UAT 6 – Total number of Bugs & CT Changes
Issue Category Number of Issues
Raised*
Bugs 242
CT Change 214
Total 456
*A full list of issues (bugs and CT changes) raised as part of UAT 6 will be available in the UAT 6 Completion Report.
• The above table details the total number of bugs and CT changes which have been
recorded internally at the EMA as a result of UAT 6 testers feedback. This total is
comprised of issues raised by both sponsors and member states.
• Details on some of the most commonly raised issues related to sponsor functionality within
the EUPD Industry workspace are listed on the following slide.
UAT update Feb-2018UAT66Summary
UAT Update (1/2)
UAT 6 – Snapshot of key issues reported*
Issue Issue description Area of the EUPD system Related use
ID case
CTCS-5824 The user is not able to download search results in csv CT Public 1041 Public Search
format in the public workspace, only txt format is
available.
CTCS-5686 Notices & alerts section needs to be more user friendly. Authority System, Sponsor System 1040 Manage tasks
The current layout is confusing to the user e.g. not in and messages
chronological order, no links to corresponding EUCT, no
sort functionality etc.
CTCS-5796 Different results in search operation when pressing only CT Public 1041 Public Search
"search" button on public workspace versus pressing
"enter" key.
CTCS-5392 Not all mandatory fields are marked with an asterisk Sponsor System, UI 1005 Populate
which results in the CTA being incomplete. country-dependent
CTA info
CTCS-5416 Notices and alerts does not show which country the Sponsor System, UI 1040 Manage tasks
notification was submitted for. and messages
CTCS-5369 Navigation section on left-hand side of the clinical trial Authority System, Sponsor System, 1005 Populate
application should be improved e.g. the countries below UI country-dependent
Part II should be indented, any fields that cannot be CTA info
selected e.g. Part II should be greyed out.
CTCS-5309 Clinical trial sites and other sections do not show latest Sponsor System 1005 Populate
information if two testers are working on the same trial. country-dependent
Conflict in information occurs and data is lost. CTA info
CTCS-5503 Document upload should be automatic when selecting Authority System, Sponsor System 1006 Upload CTA
corresponding file from local drive. Too many clicks to *A detailed breakdown of key issues will be included document
in the UAT 6 Completion Report
upload document on the CT system.
UAT update Feb-2018
CTCS-5611 Suggestion to have additional filters and details in "my Authority System, Sponsor System 1014 Invite users and
roles" section e.g. search by specific role or employer assign rolesUAT 7 Update
I. Introduction to the UAT MS representatives
II. Role of the UAT MS representatives in test scenario development
III. UAT 7 On-site test scenario scope
IV. UAT 7 Off-site approach
V. Proposed Pre-UAT 7 dates for Oct-2018
VI. UAT 7 Timeframe is currently planned for November 2018
VII. UAT next steps
28/6/2018I. Introduction to the UAT MS champions
Selection Process
1. Devise a list of scenarios with
Business
The EMA outlined input
the need for 5 Member State
representatives who could work closely with the
UAT team during the development of the Test
Scenarios for UAT 7.
The CTFG nominated 5 representatives who would
be involved in this capacity.
25II. Role of the UAT MS representatives in test scenario development
Step 01
1.
UAT Devise a
team devised
list ofdraft list of
a first
end-to-end
scenarios
scenarios. Step 02
with
Business 1. Devise
Involved UATa MS
input list of
representatives to
consult on end- Step 03
scenarios
to-end scenarios
with
in greater detail. 1. Deviseand
Discussed a
Business updated
list of the test
input scenarios with
scenarios
UAT MS Step 04
with
representatives.
Business 1. Devise
Final review a
of
input list of
the test scenarios
with the UAT MS Step 05
scenarios
representatives.
with 1. Devise
Send out theafinal
Business list of
test scenarios to
input the wider testing
scenarios
audience.
with
Business
input
Overview
- UAT team created high level end-to-end test scenarios which
were then discussed and agreed with UAT MS representatives.
- UAT MS representatives assisted with the elaboration of these test
scenario details for test scripts which will now be written by the UAT
team.
26V. Proposed Pre-UAT 7 dates for Oct-2018
Pre-UAT 7
Sep-2018 Oct-2018
Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We
03 04 05 06 07 10 11 12 13 14 17 18 19 20 21 24 25 26 27 28 01 02 03 04 05 08 09 10 11 12 15 16 17 18 19 22 23 24 25 26 29 30 31
Pre-UAT Pre-UAT
7 start 7 finish
Pre-UAT 7
execution & issues
Data raising (5 days)
Centre(s) Business / UAT MS
relocation representatives
Pre-UAT 7 issues
consolidation/triag
e (5 days) Revise and review UAT 7 test
Business / UAT MS scripts
representatives UAT / Business
Preparation for Pre-UAT 7 & UAT 7 (incl. test scripts/guidance/system Preparation for UAT 7 (incl. on-site logistics/guidance/system
testing/accounts/environment/known issues etc.) testing/accounts/environment/known issues etc.)
UAT / UAT MS representatives / Business / IT / BA / IT4U UAT / UAT MS representatives / Business / IT / BA / IT4U
Pros
1. Includes involvement of UAT Member States champions for Pre-UAT 7 execution.
2. Pre-UAT 7 will occur two weeks after the data centres relocation – less of a risk in facing configuration issues after
data centre relocation.
Cons
1. Severely reduced time for issues consolidation and test scripts updates before UAT 7.
27VI: UAT 7 Timeframe is currently planned for November 2018
UAT 7
Nov-2018 Dec-2018
Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo Tu We Th Fr Mo
01 02 05 06 07 08 09 12 13 14 15 16 19 20 21 22 23 26 27 28 29 30 03 04 05 06 07 10 11 12 13 14 17 18 19 20 21 24 25 26 27 28 31
UAT 7 UAT 7
start finish
Provisional list of Final list of bugs
bugs agreed agreed
UAT 7 off-site UAT 7 off-site
UAT 7 on-site execution execution execution TBC
(Week 1 & Week 2) (Week 3) (Week 4)
UAT 7 off-site training*
*Offsite feedback is not collected during this period
UAT 7 issues consolidation* & triage
UAT 7 issues consolidation* & triage
(Cont’d)
*Number of resources to be confirmed (after PoC) *Number of resources to be confirmed
Notes
1. UAT 7 to be conducted in Nov-2018
2. On-site execution is currently planned two weeks from 05-Nov to 16-Nov – off-site testers will be able to access the
system for training but not provide feedback during this time.
3. Off-site execution will not overlap with on-site and is currently planned to take place from the 19-Nov to 23rd-Nov-
2018
4. Possibility to extend UAT 7 is currently being considered.
5. UAT 7 Completion Report cannot be completed until early 2019 – a snapshot of findings (as in UAT 6) can be
presented in Jan-2019.
28Audit of the Clinical Trials EU portal and EU database
• EC framework contract for audit services
• Audit scope:
‒ to confirm that the EU Portal and Database meet the functional
specifications as endorsed by the EMA MB,
‒ evaluate that the system implements the use cases including the must
(auditable or non-auditable)requirements,
‒ that the system is fully functional.
29 28/6/2018Post Releases R0.7 content: Release 0.8 • System to System interfaces for Sponsors (Submission through the Gateway) • Integration with Document Management System • Audit findings & Prioritised CRs Release 0.9 • Cooperation on Safety Reporting (19 UCs) & Prioritised CRs Releases 8 and 9 have limited capacity for additional scope , some prioritised CRs (Prioritised CRs will be identified in a holistic manner from UAT 6 and UAT 7 feedback, Should requirements, WSs, functionality to address the transition phase etc) Release 1.0 (Content to be decided )- Series of Workshops organised to come up with a proposal
Summary of the status of
The Clinical Trial Portal (1/2)
• The project is running according to the plan, to deliver a fully functional IT
system, which has been reviewed by the IT task force (EMA and the external
development team).
• The coming into effect of the EU Clinical Trial Regulation is dependent on the
availability of a fully functioning portal and database, as verified by an
independent audit.
• Development of the auditable release (0.7) is progressing and this has now
entered the technical testing phase that precedes the User Acceptance
Testing (UAT).
• The schedule of this UAT is affected by the relocation of EMA’s data centre at
a different time than originally planned and the UAT for release 0.7 is now
foreseen for November 2018.
31Summary of the status of
The Clinical Trial Portal (2/2)
• Taking into account the relocation of the Agency in early March 2019 and the
possible staff loss, the potential impact on the precise timing of the audit is
currently being assessed
• Release 0.8 is primarily focused on addressing audit findings, and prioritised
change requests from UATs 6 and 7, focussing on those necessary for a
successful audit outcome.
• EMA will provide more precise information on overall timelines after the
audit.
32File posted by EMA on July 25th 2018
33Training approach
Support through guidance
documentation
Support through E-Learning Detailed guidance documentation
Most of the training will be and user guides will be produced to
delivered via information videos. explain the functionality of each
These will be produced in house module detailing step by step how
and will consists of approximately the system should be used. All the
15 e-learning modules with some documents will be made available
modules comprised of multiple E-learning through the EMA corporate website.
videos. The videos will be In addition, ‘contextual help’
published on the EMA corporate information will be available online
website and the Network Training User guides/ in the EUPD Web interface.
Centre (NTC) over the course of Supporting
2018 and 2019. doc
Integrated
learning
materials
Face to face
Webinars
Support through webinars
A series of webinars will be organised over the
Support through face to face course of Q4 2018/Q1 2019 targeted at MSs
Face to face training will be EUPD and sponsors/MAHs. Participants will be
training course for MSs and reminded 10 days in advance to provide
industry. Train the trainer questions (this will help us to start the webinar
sessions will be planned with DIA session) and they will have the opportunity to
to to deliver in-house training. ask questions during the webinars.Thank you
Questions?
35Critical points of CTR
Archive of essential documents for 25 years
Single site Investigator Initiated trial in small hospitals requires
specific skills to activate the procedure through the Portal
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