Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF

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Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
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
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
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
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
EUCROF September – 2018
Geographic Representativeness

   EUCROF Members & Associates   EUCROF Partners
   Relationship in development
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
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
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
Clinical Trials Migration

                            5
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
European Commission Intent in 2012

                                     6
Updates on the new EU Clinical Trial Portal - 3rd Annual Clinical Trials Quality & Compliance 13-14 September 2018 - EUCROF
…. And that’s the outcome……

                              7
EU 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

                                                                                            8
What 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 perspective
Collaborative 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 Update
EU 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 Update
EU 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 Update
Actions by the user

Left inside                         Right inside
navigation                          navigation
What the public sees

                       17
How to search in the database

                           Ricerca
                           avanzata

                                      18
Results of the search

                        19
Introduction 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

    20
UAT66Summary
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-2018
UAT66Summary
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-2018
UAT66Summary
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 roles
UAT 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

                                                                     28/6/2018
I. 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.

25
II. 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.
  26
V. 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.

     27
VI: 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.

     28
Audit 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                                                                         28/6/2018
Post 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.

                                                                                   31
Summary 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.

                                                                                    32
File posted by EMA on July 25th 2018

                                       33
Training 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?
             35
Critical 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

                                                                       36
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