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 May 02, 2023

2:00 PM — 2:30 PM

Welcome and Introduction

2:30 PM — 6:30 PM

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

Day 2 May 03, 2023

2:00 PM — 6:30 PM

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

Day 3 May 04, 2023

2:00 PM — 6:30 PM

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

Day 4 May 05, 2023

2:00 PM — 6:30 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.