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Apr 05, 2022 2:00 PM - Apr 08, 2022 6:30 PM

(Central Europe Standard Time)

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.


2:00 PM2:30 PM

Welcome and Introduction

2:30 PM6:30 PM

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

2:00 PM6:30 PM

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

2:00 PM6:30 PM

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

2:00 PM6:30 PM

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

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