Clinical Trials Information System (CTIS) bitesize talk: Annual safety report (ASR)

Date: 15/12/2022
Location: Online, 14:30 - 16:00 Amsterdam time (CET)

Event summary

CTIS is the business tool of the EU Clinical Trials Regulation (Regulation (EU) No 536/2014) and it acts as a single entry point for clinical trial authorisation and supervision in the European Economic Area.

This bitesize talk on CTIS provides an opportunity for sponsors to learn about the Annual Safety Report that is submitted via CTIS. Sponsors will also have opportunity to ask questions on this CTIS topic during the event.

To be better prepared for this event, sponsors are encouraged to consult the CTIS training and support materials, focusing on the e-learning course of Module 19 (How to create and submit an ASR and respond to related RFIs) of the online modular training programme, as well as the CTIS Structured data forms on Annual Safety Report.

The event is open to all sponsor organisations, including pharmaceutical companies, contract research organisations, small and medium-sized enterprises (SMEs) and academic organisations. EMA cannot provide participants certificates of attendance for this event.

CTIS Bitesize talks are live broadcast and no registration is required for those wishing to follow the live broadcast on EMA’s website.

A video recording is made available after the event. Processing and publication of the video recording typically takes up to 60 days. Please subscribe to the Clinical Trials newsletter for updates on the availability of CTIS event video recordings.

Questions submitted via Slido

Participants are able to make use of the audience interaction tool Slido to ask questions in two phases:
 - up until one work day in advance, i.e. until 13 December 2022
 - and also during the event on 15 December 2022

Please go to slido event to submit your questions and up vote questions you would like to see answered during the live event.

Interaction via Slido is voluntary, and you may opt to remain anonymous. If you chose to use Slido, you consent to the processing of your personal data as explained in the EMA data privacy statement for Slido.

Live broadcast - 14:30 - 16:00 Amsterdam time (CET)

You should see the live broadcast on pressing the 'play' icon in the video window, or a message stating that we are not currently broadcasting.

To optimise video quality, once the video is playing we recommend clicking on the ‘HD’ symbol in the video window then selecting the '720p' option.

If the video window is blank, or if you experience other difficulties viewing the broadcast, please try connecting directly to the IBM channel.

For technical information about the required network security settings, please see this IBM help page.

For further assistance, please consult the EMA service desk.

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