EMA Clinical Trials Information System - Sponsor user training programme

Practical, hands-on training course on CTIS system functionalities including the creation and submission of an initial application, respond to RFIs, submitting a substantional modification, search and download options. Participants receive access to the CTIS training environment and will practice basic functionalities during the live training course.

Agenda

Day 1 Sep 19, 2023

9:00 AM — 9:30 AM

Welcome and Introduction

9:30 AM — 1:30 PM

Overview of CTIS components & functionalities, sponsor user access management, sponsors roles and permissions,

Day 2 Sep 20, 2023

9:00 AM — 1:30 PM

Create, submit, cancel and withdraw an initial application, respond to Request For Information (RFI)

Day 3 Sep 21, 2023

9:00 AM — 1:30 PM

Update an initial application - substantial & non-substantial modification, manage a clinical trial through CTIS

Day 4 Sep 22, 2023

9:00 AM — 1:30 PM

Sponsor view, search and download options, create & submit an Annual Safety Report (ASR), Clinical Study Report (CSR) submission

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EMA Clinical Trials Information System - Sponsor user training programme

Agenda

Be informed and stay engaged.