1. The CTR implementation at national level in Belgium
Information session for ECs
25th of April 2019

2. Agenda EC recognition (Law 7/5/2017) : update Feedback Pilot project
Feedback of the working groups
WG ICF
WG AR and flow
BAREC
Feedback IT (EU and BE)
EU Portal
BEATIS
AOB

3. 1. EC recognition (Law 7/5/2017): update
Deadline submission
Decision
# ECs
# ECs phase 1
1/5/2018
1/10/2018 1
1/11/2018
1/4/2019 4 3
1/5/2019
1/10/2019
1/11/2019
1/4/2020
1/5/2020
1/10/2020
In time?

4. 2. Feedback Pilot project A
2. Feedback Pilot project A. State of affairs (Sébastien Vanhiesbecq, FPS Health)
Dossiers submitted (02/04/2019)

5. 2. Feedback Pilot project A. State of affairs
Dossiers evaluated (02/04/2019)
Number of dossiers with a final decision (initials + SM)
2017
9 dossiers
2018
68 dossiers
2019
34 dossiers
Withdrawn =
removal from sponsor

6. 2. Feedback Pilot project A. State of affairs
Initial dossier (phases) (02/04/2019)

7. 2. Feedback Pilot project A. State of affairs
Approval vs Conditional approval (02/04/2019)
As described in section 3.5 of the WPF doc :
If the conditions after the 2nd round are not essential before the trial starts, prefer the approval letter with recommendations instead of approval letter with conditions

8. 2. Feedback Pilot project A. State of affairs
VHP+
Currently, 3 Ethics Committees are interested to participate to the evaluation of the VHP+ dossier
The NCP received a letter of intent for the first VHP+ dossier in BE (pilot 093):
Belgium as concerned Member State (cMS)
Submission date : June 2019
Participating sites : not yet known
Practical procedure :
Both submissions (part I and part II) will be pre-submissions
Part II of the dossier (with the exception of the written statement) submitted to the BE NCP in parallel with Part I and at the same moment
Timelines for evaluation differ for Part I and Part II
National legal submission of both parts would occur after the end of the VHP process
Approval will be an administrative approval for both parts, within 10 days

9. 2. Feedback Pilot project B
2. Feedback Pilot project B. Tips and Tricks (Julien Frgacic, FPS Health)
- use the last versions of our templates (AR, letters,…) available on google drive
→ A lighter version of the AR part II is available (for word 2010 or higher)
all the instructions for the sponsor should be written in english !
- questions for the Sponsor (RFI) must be clear ! Keep in mind that the sponsor has no access to the Assessment Report.

10. 2. Feedback Pilot project B. Tips and Tricks
approval letter : list of documents on the basis of which the conclusion was made
Please indicate the versions and the date of the documents !
In case of SM: be aware not to mention the documents from the initial application !
In case of RFI : be aware to take into account additional and modified documents

11. 2. Feedback Pilot project B. Tips and Tricks
Good Example 1 (initiative of an EC):
List of documents on the basis of which the conclusion was made
PART I
A. INTRODUCTION AND GENERAL PRINCIPLES
Pilot000_ _submission dated 14 November 2018
B. COVER LETTER
Pilot000_ _cover_letter dated 19 November 2018
Pilot000_ _78_reply_cover_letter dated 19 February 2019
C. EU APPLICATION FORM
Pilot000_ _application_form dated 29 January 2019
D. PROTOCOL
Pilot000_ _protocol version 3.0 dated 19 February 2019

12. 2. Feedback Pilot project B. Tips and Tricks
Good Example 2 (initiative of a sponsor):

13. 2. Feedback Pilot project B. Tips and Tricks
There cannot be any conditional approval or refusal at T20
Only an approval is possible at that time
Indeed the sponsor still has the opportunity to response to your Committee’s questions (T23bis)
- Do not forget to mention pilot number and EudraCT

14. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
What has been done since January?
3 meetings : 19/2; 14/3; 02/04/2019
Agenda items:
Discussed comments of reviewers (EN)
Discuss translations into FR/NL
Results readability test lay-persons, using mock-ICF v2.0

15. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Mock-up ICF
2 page summary (Trial at a glance)
Introduction , rights in brief
Chapter I trial specific, in brief *
Chapter II trial specific, in detail
Chapter III, generic rights *
Chapter IV, consent
References
Mock-up ICF v 2.0
2-3 page summary (Trial at a glance + rights in brief)
Chapter I trial specific, in brief + generic rights
Chapter II trial specific, in detail
Chapter III, consent
Glossary
References
Readability test lay-persons 2.0

16. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Major results from readability tests v2.0 (n=27)
+ Trial at a glance is appreciated !
- ICF is not easy to read (legal texts) & too long!
- Why trial specific parts of ICF are spread over two chapters? Repetitions?
- Not clear yet:
which costs are paid by the sponsor
who has access to personal data

17. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Mock-up ICF 2.0
2-3 page summary (Trial at a glance + rights in brief)
Chapter I trial specific, in brief + generic rights
Chapter II trial specific, in detail
Chapter III, consent
Glossary
References
Template ICF
Trial at a glance: summary incl. rights
Chapter I: trial specific + generic rights
Chapter II: consent
Glossary
References

18. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Trial at a glance (summary)
Incl. rights in brief
Max. 3 pages
Guidance for sponsor: list of questions to be answered in this chapter
An example will be published
Generic rights are spread over sections in chapter I
Text can not be “read-only” for the sponsor (> impact on fluency)
Generic rights will be published as a separate brochure > Information Brochure
Sponsor will have to add a statement to describe the adaptations made to generic rights (+ motivate why)

19. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Major results from readability tests v2.0 (n=27)
Trial at a glance is appreciated !
ICF is not easy to read (legal texts) & too long!
Why trial specific parts of ICF are spread over two chapters? Repetitions?
Not clear yet:
which costs are paid by the sponsor
who has access to personal data

20. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Which costs are paid by the sponsor? Proposal WG:
Add Annex to ICF, including
flow charts of the trial
AND
which examinations/treatments are SOC vs Trial Specific
Annex to be provided post-approval as a notification (to evaluating EC?)
Opinion requested from RUZB/CHAB on this proposal > answer by 30/4

21. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Transition period of 6 months
the use of the template (incl. “Trial at a glance”, the Annex on financial aspects, the ICF statement of the sponsor) will become highly recommended for all new CTA’s, 6 months after publication of the template on the website of the CT-College
GDPR aspects should already be implemented now

22. 3. Feedback working groups A. Working group ICF Template (K
3. Feedback working groups A. Working group ICF Template (K. Anciaux; FPS Health)
Next steps?
ICF template & Information Brochure (with generic rights)
Content: Finalize discussions in WG
Ask advice from Belgian DPA
Lay-out > Publish > Communicate
APR
JUN

23. Monitor and improve procedures
3. Feedback working groups B. WG AR and flow (Lisa Marynen; FPS Health)
Collaboration CT-College – FAMPH – ECs
EC representatives: UZ Gent, Erasme, UZ Leuven, J. Bordet,
AZ Delta, OLVZ Aalst, UZ Brussel
Focus on practical implementation of the new
evaluation process and the pilot project
2018: 9 meetings
2019: 31/1; 28/2; 28/3; 25/4, planned dates 23/5; 20/6
=> 3 meetings since last information session
Discuss issues
Monitor and improve procedures
Develop procedures

24. 3. Feedback working groups B. WG AR and flow
Important topics discussed (1/2):
VHP + procedure
Part II document harmonisation (EU WG)
Working group to discuss harmonisation of part II documents between member states
First EU template: CV => will be added by the FAMHP to the sponsor guidance
Update EC recognition and EC payments for the Law of 2017 (debt declarations!)
Feedback EU portal

25. 3. Feedback working groups B. WG AR and flow
New version of the workprocessflow will be sent/published post meeting
Important topics discussed (2/2):
Pilot project workprocessflow
Timelines SM ATMP
Notifications e. g. change of legal representative
Written statement
maximum validity of the investigator’s GCP certificate: max. 3y ….
Feedback BFARM training April 2-3 (R. Storme)
Feedback report (see next slides)

26. 3. Feedback working groups B. WG AR and flow
Law 7 May 2017: Roles of the CT-College
Single point of contact FAMHP and ECs
Coordination of EC activities
Selection of EC in charge of evaluation
Objective criteria defined by RD
Cannot be the EC of the study site(s)
Harmonisation of EC procedures - > since only 1 EC evaluates
Quality Assurance of Ecs
The college does not take part in the evaluation
- Feedback report

27. 3. Feedback working groups B. WG AR and flow
- Feedback report
FAMHP
College
Survey completed by sponsor
Survey completed by EC
Sponsor
Regular meetings ?
RFI
&
single decision EC

28. 3. Feedback working groups B. WG AR and flow
Transfer process
The AR and decision letter were provided in time.
YES NO
Eudralink was used to provide the AR.
All parts of the AR were sent in one message.
The AR was provided as MS-WORD.
The EUDRACT and pilot number were included in each file name. AR
All applicable questions were treated.
Only blank workspaces were completed
All “considerations” were copied to the “List of questions to the sponsor”. NA
The questions to the sponsor were clearly formulated.
All comments and questions were formulated in English, unless linguistic comments on non-English documents.
Decision letter
All applicable sections were completed.
All (not)authorized trial sites and investigators are mentioned.
The list of documents (incl. version number and date) was complete.
If applicable, the conditions (or recommendations) were formulated clearly.
If applicable, the conditions (or recommendations) were formulated in English, unless linguistic comments on non-English documents.
The decision corresponds with the advice in the AR.
- Feedback report

29. 3. Feedback working groups C. BAREC
Christel Vansteenkiste

30. Workgroups: rationale & overview
Sharing concerns and experiences
Address issues within common frame
Objective: develop advices and consensus within BAREC, as representative of Belgian Ethics Committees involved in clinical research.
WG Medical devices
WG Biobank & GDPR
WG Remaining part of the law on experiments dd 7/5/2004.
WG Harmonisation of the Ethics Committees’ daily practice.

31. WG medical devices Overall objective:
to work on the translation of the new European law text (new regulation on clinical investigations) into national legislation
In consultation with other parties involved

32. WG Biobank & GDPR Main objective:
to achieve consensus within BAREC about interpretation and concrete implementation of the current legislations
in consultation with other partners involved (workgroup on Biobank of the FAMHP)

33. WG Remaining part of the law on experiments dd 7/5/2004
Main objective:
to work on the revision of the law of 7/5/2004 regarding experiments on human beings (remaining part after implementation of the CTR and future implementation of the European regulation concerning medical devices).

34. WG Harmonisation of the ECs’daily practice
Objective:
to streamline procedures and daily work of our ethics committees.

35. 4. Feedback IT projects A. CTIS- Portal (Pieter Vankeerberghen, FAMHP)
The project hand over to a new consultant is done. This consultant does analysis and development together (more consistency)
EMA, consultant Everis, member states (6 champions) very much involved. Champions prioritised (into *three classes) approx 680 items.
Champions asked and obtained sandbox to assist in the prioritisation efforts.
Recent call for more participation.
The group above is writing a product vision document, with release planning in it (*corresponding with the three classes: for audit, for go live and post go live). No date yet for audit.
Training for users (both sponsors and Authority, college, EC’s) is essential.

36. 4. Feedback IT B. BEATIS (Julien)
Application for management of clinical trials (in the frame of the belgian pilot project)
It is an internal application for the College that contains 2 main sections :
- One dedicated to the EC selection (described in RD)
- One dedicated to the dossier management
The application is still being improved and will be hopefully usable on a regular basis in June at the latest.

37. 5. AOB
Next information session: 26th of September 2019, 19.30h