EMA Clinical Trials Information System - Sponsor user training programme

Demonstrations and explanations of the system functionalities including initial application, RFIs, submitting a modification, search and download options etc.

Agenda

Day 1 May 10, 2022

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 May 11, 2022

9:00 AM — 1:30 PM

Workload management - create, submit initial application, respond to Request For Information (RFI)

Day 3 May 12, 2022

9:00 AM — 1:30 PM

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

Day 4 May 13, 2022

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.