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

Online

03/12/2021

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

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