Facilitating European Clinical Research

ECRIN is a public, non-profit organisation that links scientific partners and networks across Europe
to facilitate multinational clinical research. We provide sponsors and investigators with advice,
management services and tools to overcome hurdles to multinational trials and enhance collaboration.

Our Work

We provide our 12 member and observer countries with diverse trial support services
and contribute to 'infrastructure development' projects with additional European and international partners.

ECRIN in Numbers

Member & Observer Countries

Million citizens represented

Trials in ECRIN portfolio

Average # of countries per trial

Events

Date:

The EU-Africa PerMed project funded by the European Commission's H2020 framework programme seeks to develop international collaborations and identify future actions in personalised medicine to be established between Africa and Europe. The objective is to build a lasting relationship between these two continents in terms of research, development, innovation and implementation for a better integration of the African needs in the international agenda for personalised medicine.

During two dedicated information days, one in English and one in French language, the EU-Africa PerMed project, its objectives, planned activities and expected results will be presented. The information days are thought of as warm-up events prior to the 1st stakeholder workshop that will take place in Kenya on the 9th and 10th of February 2022.

Together with the presentation of the EU-Africa PerMed project, there will be a talk by the European Commission, Directorate-General of Research and Innovation, as funder of the project, and a short presentation of the International Consortium for Personalised Medicine (ICPerMed).

Two 1-hour sessions are planned:

  • 1st December 2021 at 11:00 am (CET) – in English
  • 13th December 2021 at 11:00 am (CET) – in French

Agenda:

  • 11:00-11:10  Opening of the webinar
  • 11:10-11:20  Welcome from the European Commission
  • 11:20-11:35  The EU-Africa PerMed project
  • 11:35-11:45  The ICPerMed consortium
  • 11:45-11:55  Q&A / Discussion
  • 11:55-12:00  Closing remarks

The webinar is open to everybody but registration is required.

To register, please visit the EU-Africa PerMed website: https://www.euafrica-permed.eu/ 

Pour les informations en français veuillez consulter ce document

Date:

Together with EMA, ECRIN will co-host a session 3 December 2021 (9:00-13:00 CET) to support academic organisations as they look to implement CTIS. This event is developed for the ECRIN CTU community and it will include live demonstrations and Q&A to address your most pressing questions as the CTIS launch approaches. This is a free event.

To attend this training it is important that all participants have familiarised themselves with the information available on the EMA website and more specifically the modules listed below:

  • Module 19: SME and academia module as a start - General overview of CTIS functionalities
  • Modules 3 and 7 – user registration, users management (Topic 1)
  • Module 10 – completion of a clinical trials application (Topic 2 and 4)
  • Module 11 – RFI and RFI responses (Topic 3)
  • Sponsor handbook

For more details see the links provided at the end of this event page.

Registration

Registration is available here to members of ECRIN CTUs: REGISTER NOW

Please find the updated Terms and Conditions of the meeting here

Agenda

Chaired by Ralf Herold, Scientific Officer in the Regulatory Science and Innovation Task Force - Research and Innovation, EMA  and Sabine Klager, Head of Clinical Operations, ECRIN

Topic

Speaker

Time

Introduction and welcome by the co-chairs

Ralf Herold & Sabine Klager

5 mins

Topic 1: CTIS Access and User Management:

- Prerequisite to access CTIS : EMA account

- Organisation modelling for CTIS: access to CTIS, user personas and user roles

- Role assignment in an organisation centric approach vs the CT centric approach and the role of a CT Admin

- Overview of users roles and corresponding actions in CTIS

Introductory PPT followed by live demo

Ana Rodriguez,

EMA

45 mins

Q&A session on the topic

All

10 mins

BREAK

 

5 mins

Topic 2: Completion of an initial application

- Detailed description of CTA structure, data and documents to be populated by the sponsors in CTIS in the form, part I and part II

- How to request a deferral and its implications

- How to retrieve organisations details from OMS

- How to retrieve product details from XEVMPD

Introductory PPT followed by live demo

Laura Pioppo,

EMA

45 mins

Q&A session on the topic

All

10 mins

BREAK

 

5 mins

Topic 3: Modifications to an initial application – under evaluation - via RFI  (Request for information)

- How RFI can be raised by RMS/MSC directly in CTIS

- How is the sponsor aware of an RFI being raised

- How can a sponsor reply to an RFI

- What are the implications if an RFI is not addressed on time

Introductory PPT followed by live demo

Charalampos Drosos,

EMA

45 mins

Q&A session on the topic

All

10 mins

                                          BREAK

 

5 mins

Topic 4: Modifications to an authorised initial application via modifications and adding a new MSC

- Substantial modifications (part I/ part II / part I and II)

- Non substantial modifications

- Adding a new MSC

Introductory PPT followed by live demo and Q&A

Andrea Seidel-Glätzer

KKS, University of Heidelberg

45 mins

Closing remarks and location of training materials and support

 

ECRIN & EMA

10 mins

 

 

Useful links to available training material 

M07: e-learning & 1 video

https://www.ema.europa.eu/en/learning-module/management-roles/story.html

https://www.youtube.com/watch?v=hfzZxwX2W-Y&ab_channel=EuropeanMedicinesAgency

M10: 3 videos

https://www.youtube.com/watch?v=1du3VUq4K5g&ab_channel=EuropeanMedicinesAgency

https://www.youtube.com/watch?v=piRl9ZGTe-Y&ab_channel=EuropeanMedicinesAgency

https://www.youtube.com/watch?v=jmylMwZFroc&ab_channel=EuropeanMedicinesAgency

M11: e-learning

https://www.ema.europa.eu/en/learning-module/respond-to-rfis-ctis/story.html

 

For any questions on the event please contact media@ecrin.org

Date:

Due to the change in the pandemic situation, the launch has been postponed. 

 

EU-AMRI, the European Alliance of Medical Research Infrastructures, is the new alliance between the European medical research Infrastructures BBMRI, EATRIS and ECRIN. EU-AMRI aims to facilitate the effective and efficient use of scientific services, expertise and tools by academia and industry for the seamless translation of their scientific discoveries into new treatments and solutions for patients. The end goal of EU-AMRI is to make it easier for the broader research community to achieve their goals by delivering scientific services with the highest standards of quality and reproducibility.