Overview

A practical walkthrough of working in CTIS. While issues related to the Clinical Trial Regulation will be addressed, the focus of this workshop is the day-to-day working environment for sponsor users and administrators of CTIS, with heavy emphasis on understanding the public disclosure aspects of information submitted to CTIS.

Audience:
- Individuals who are or plan to use CTIS daily or administer CTIS users

- Organizations without a representative in the EMA CTIS Sponsor Master Trainer Programme

- Those completely new to the Clinical Trial Regulation and the CTIS Sponsor Workspace are welcome, but should view the recommended Pre-reads as mandatory. At a minimum, read the CTIS Sponsor Handbook and view the brief EMA Youtube videos linked to in CTIS Modules 5, 9, 10 and 11.

- Pre Reads -Regulation EU 536/2014, EMA’s CTIS Sponsor Handbook (Version 2),European Commission’s CTR Q&A (Version 6.1 or later) and CTIS Modules 5, 9, 10, 11, 13 and 18.

Objectives:

- Understanding the transparency impacts of CTIS, including sponsor obligations under GDPR

- Understand how to best utilize existing EMA CTIS training materials.

- Walkthrough of an Initial Clinical Trial Application in CTIS

- Troubleshooting and use of the EMA Service Desk

- Understand how CTIS interacts with other EMA systems (e.g IAM, OMS, xEVMPD, SPOR)

- Transitioning of ongoing studies from the Directive to the Clinical Trial Regulation

- Best practices for responding to Validation and Assessment Requests for Information (RFIs)

Workshop Agenda:

12:00   Registration and Welcome

12:10   CTIS Overview and 2022 Update  

12:45  Break 
 
13:00 Walkthrough of an Initial Clinical Trial Application Submisison
Scott Feiner, Senior Manager, Clinical Records Management, AbbVie, USA

14:00 Q&A

14:20 Break

14:30 Walkthrough of the RFI Response Process

Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA
 
15:00 Translational Trial Applications in CTIS

15:20 Notifications in CTIS

15:40 Substantial and Non Substantial Modifications, Additional Member State Concerned Application

16:00 Annual Safety Reporting in CTIS

16:15 How to troubleshoot CTIS and efficient use of the EMA Service Desk

16:25 Break

16:35 Q & A or Round Table Discussion

Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA

17:30 End of Pre-conference Workshop