updates on the new eu clinical trial portal€¦ · updates on the new eu clinical trial portal dr....

Updates on the new EU Clinical Trial Portal

Dr. Stefano Marini EUCROF Vice-President European Contract Research Organization Federation 13-14 September 2018

3rd Annual Clinical Trials Quality & Compliance 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

Associate Members 1. Albania

2. Austria

3. Bulgaria

4. Denmark

5. Germany

6. Portugal

7. Serbia

8. Switzerland

9. Ukraine

10. United Kingdom

TOTAL: >352 Companies, 23 Countries , over 23.000 employees

2

National Member Associations Country N. CROs

1. ACRO-CZ Czech Republic 18

2. ACRON The Netherlands 45

3. AECIC Spain 28

4. AFCROs France 70

5. AICRO Italy 23

6. ASCRO Sweden 13

7. BeCRO Belgium 29

8. BVMA Germany 42

9. CCRA United Kingdom 36

10. HACRO Greece 10

11.SAKDER Turkey 26

12. SACROP Slovakia 21

Partner Members 1. Algeria

2. Israel

3. Lebanon

EUCROF September – 2018 Geographic Representativeness

EUCROF Members & Associates Relationship in development

EUCROF Partners

Number of Clinical Studies in EU

4

YEAR Eudract

Numbers issued in EU

2011 6.011

2012 5.399

2013 5.406

2014 5.549

2015 5.526

2016 5.144

Nov 2017 4.742*

Aug 2018 3.309

0

1.000

2.000

3.000

4.000

5.000

6.000

7.000

Eudract Numbers issued in EU

Eudract Numbers issuedin EU

* Data on Dec 2017 not available

Clinical Trials Migration

5

European Commission Intent in 2012

6

…. And that’s the outcome……

7

EU Clinical Trial Portal definition

8

• 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

EU PORTAL

AND

DATABASE

(Art 80-84)

SAFETY

REPORTING

(Art. 40 and 44)

EUDRACT

LEGACY

(Art 98)

• Single EU entry point for clinical trial applications

• Collaboration in the evaluation and supervision at EU level

• Provides workspace collaboration tools, workflow and document management capabilities

• Provides publicly available information

• Delivers a module for the electronic reporting of suspected unexpected serious adverse reactions (SUSARs)

• Delivers an electronic reporting system for annual safety reports (ASRs)

• Delivers transition between the current and new systems

What should the Agency deliver?

9 Implementation of the new Clinical Trial Regulation (EU) No 536/2014 - EMA perspective

STAKEHOLDERS - Sponsors - CROs - Health Care Professionals - Patient Representatives

EUROPEAN MEDICINES AGENCY

EUROPEAN COMMISSION

MEMBER STATES & ETHICS

COMMITEES

Collaborative working

The EMA is working collaboratively

to develop systems to implement the regulation

EU Portal and Database Update 10

Presented by Anabela Marcal Head of Committees and Inspections Department European Medicines Agency

CT Portal/ EU DB

Business Processes

System Interfaces

CT Systems

Sponsors

Secure Access

Open

Access

NCAs and Ethics Committees EC EMA MA Applicant Public

CT DB Public DB

Create Application

Evaluate Application

Supervise CT

Manage Reports

Submit CSR Disseminate CT Info

Issue Notification

Submit Results

Manage Users

Manage Publication

Access CT Info

MS Interface

Sponsor’s Interface

Business Intelligence

Industry System

Authority System

Workflow Engine

CT Public Register

EU portal and database – High Level System Overview (2/2)

BI Reports UI Authority Workspace

Sponsors Workspace

Public Website


Master Data Management (RMS/OMS)

Data Warehouse

(DWH)

User Registration & Security

(IAM)

Document Management

(DMS)

EMA

WHO

Sponsors

EV Human

MSs

EU portal and database – System Interfaces

Business Processes

System Interfaces

CT Systems

CT Portal/EU DB

CT DB Public DB

12

Confidential work area where Sponsors can prepare and compile data and information to

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

• Trials current status overview

• Access CT Application Dossier

• Submit new Applications

My CTs

Overview &

Search

Requests for

information &

notices

Sponsor Workspace Overview -Key Features for Sponsors

Sponsors Workspace

• View detailed application dossier (data

and documents)

• Manage my Trial (Complete application

dossier for new / updated trial, issue

Notifications etc)

• Download data and documents

CT

Application

Dossier

• See all alerts and notices for all my trials

• Get reminders for important deadlines

My

Notices &

Alerts

• See formal or informal requests for

information from Member States and

respond

• See deadlines for responses

• Prepare responses to RFI

My

Requests for

Information

• Invite users to access trials

•Assign roles to users for trials

• 2 different approaches: Organisation

Centric vs CT centric

User

Management

• Imports CT Applications, Notifications and

Trial Results to the Sponsor Workspace

Sponsors

Interface


Actions by the user

Left inside navigation

Right inside navigation

What the public sees

17

How to search in the database

18

Ricerca avanzata

Results of the search

19

Introduction to 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

What is User Acceptance Testing (UAT)?

20

UAT verifies the system has the right features

Other test types verify the system has no significant bugs

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 6 Summary (1/2) UAT 6 Update

UAT update Feb-2018


UAT 6 – Total number of Bugs & CT Changes

*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

Issue Category Number of Issues Raised*

Bugs 242

CT Change 214

Total 456


UAT 6 – Snapshot of key issues reported*

*A detailed breakdown of key issues will be included in the UAT 6 Completion Report

UAT update Feb-2018

Issue ID

Issue description Area of the EUPD system Related use case

CTCS-5824 The user is not able to download search results in csv

format in the public workspace, only txt format is

available.

CT Public 1041 Public Search

CTCS-5686 Notices & alerts section needs to be more user friendly.

The current layout is confusing to the user e.g. not in

chronological order, no links to corresponding EUCT, no

sort functionality etc.

Authority System, Sponsor System 1040 Manage tasks

and messages

CTCS-5796 Different results in search operation when pressing only

"search" button on public workspace versus pressing

"enter" key.

CT Public 1041 Public Search

CTCS-5392 Not all mandatory fields are marked with an asterisk

which results in the CTA being incomplete.

Sponsor System, UI 1005 Populate

country-dependent

CTA info

CTCS-5416 Notices and alerts does not show which country the

notification was submitted for.

Sponsor System, UI 1040 Manage tasks

and messages

CTCS-5369 Navigation section on left-hand side of the clinical trial

application should be improved e.g. the countries below

Part II should be indented, any fields that cannot be

selected e.g. Part II should be greyed out.

Authority System, Sponsor System,

UI

1005 Populate

country-dependent

CTA info

CTCS-5309 Clinical trial sites and other sections do not show latest

information if two testers are working on the same trial.

Conflict in information occurs and data is lost.

Sponsor System 1005 Populate

country-dependent

CTA info

CTCS-5503 Document upload should be automatic when selecting

corresponding file from local drive. Too many clicks to

upload document on the CT system.

Authority System, Sponsor System 1006 Upload CTA

document

CTCS-5611 Suggestion to have additional filters and details in "my

roles" section e.g. search by specific role or employer

etc.

Authority System, Sponsor System 1014 Invite users and

assign roles

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

UAT 7 Update

28/6/2018

25

I. Introduction to the UAT MS champions

1. Devise a list of scenarios with

Business input

Selection Process

The EMA outlined 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.

26

II. Role of the UAT MS representatives in test scenario development

1. Devise a list of scenarios with Business input

UAT team devised a first draft list of end-to-end scenarios.

Step 01


Step 02


Step 03


Step 04


Step 05

Involved UAT MS representatives to consult on end-to-end scenarios in greater detail. Discussed and

updated the test scenarios with UAT MS representatives.

Final review of the test scenarios with the UAT MS representatives.

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.

Send out the final test scenarios to the wider testing audience.

27

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 7 start

Pre-UAT 7 finish

Pre-UAT 7 execution & issues

raising (5 days)

Business / UAT MS representatives

Data Centre(s) relocation

Preparation for Pre-UAT 7 & UAT 7 (incl. test scripts/guidance/system testing/accounts/environment/known issues etc.)

UAT / UAT MS representatives / Business / IT / BA / IT4U

Preparation for UAT 7 (incl. on-site logistics/guidance/system testing/accounts/environment/known issues etc.)

UAT / UAT MS representatives / Business / IT / BA / IT4U

Pre-UAT 7 issues consolidation/triag

e (5 days)

Business / UAT MS representatives

Revise and review UAT 7 test scripts

UAT / Business

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.

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

VI: UAT 7 Timeframe is currently planned for November 2018

UAT 7 start

UAT 7 finish

UAT 7 on-site execution (Week 1 & Week 2)

*Number of resources to be confirmed (after PoC)

Provisional list of bugs agreed

Final list of bugs agreed

UAT 7 off-site execution (Week 3)

UAT 7 issues consolidation* & triage

UAT 7 off-site training*

UAT 7 issues consolidation* & triage (Cont’d)

*Offsite feedback is not collected during this period

TBC

UAT 7 off-site execution (Week 4)

*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

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

Post Releases R0.7 content:

Summary of the status of The Clinical Trial Portal (1/2)

31

• 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.

Summary of the status of The Clinical Trial Portal (2/2)

32

• 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.

File posted by EMA on July 25th 2018

33

User guides/ Supporting doc

E-learning

Face to face

Webinars

Training approach

Integrated learning materials

Support through guidance documentation Detailed guidance documentation and user guides will be produced to explain the functionality of each module detailing step by step how the system should be used. All the documents will be made available through the EMA corporate website. In addition, ‘contextual help’ information will be available online in the EUPD Web interface.

Support through webinars A series of webinars will be organised over the course of Q4 2018/Q1 2019 targeted at MSs and sponsors/MAHs. Participants will be reminded 10 days in advance to provide questions (this will help us to start the webinar session) and they will have the opportunity to ask questions during the webinars.

Support through face to face Face to face training will be EUPD training course for MSs and industry. Train the trainer sessions will be planned with DIA to to deliver in-house training.

Support through E-Learning Most of the training will be delivered via information videos. These will be produced in house and will consists of approximately 15 e-learning modules with some modules comprised of multiple videos. The videos will be published on the EMA corporate website and the Network Training Centre (NTC) over the course of 2018 and 2019.

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

updates on the new eu clinical trial portal€¦ · updates on the new eu clinical trial portal dr....

Documents