EMA/ECRIN joint training session - Implementation of the Clinical Trial Regulation (EU) No 536/2014 for academia: Live demonstration of CTIS and Q&A session

Date(s)
03 December - 03 December 2021
Location
Online

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