概要
Overview:
A detailed description of the CTIS environment. While issues related to the Clinical Trial Regulation will be addressed, the focus of this workshop is the 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 plan to use CTIS daily or administer CTIS users
- Organizations without a representative in the EMA CTIS Sponsor Master Trainer Programme
- Strongly recommend attendees have a familiarity with Regulation EU 536/2014 and the EMA’s CTIS Sponsor Handbook
Objectives:
- Understanding the transparency impacts of CTIS, including sponsor obligations under GDPR
- Best practices for interacting with CTIS, tailored to your organization structure
- Understand how CTIS interacts with other EMA systems (e.g IAM, OMS, xEVMPD, SPOR)
- What can be done today to prepare your organization for CTIS;
- How your internal organization structure impacts work within CTIS (workload)
- Understand how to best utilize existing EMA CTIS training materials.
Workshop Agenda:
13:45 Participants Log-In and Connect
14:00 Intro to CTIS and Best Practices
Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA
14:45 Break
15:00 Disclosure Best Practices in CTIS: Disclosure, Redactions, Deferrals
Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA
16:15 Break
16:30 How Does CTIS interact with other Systems? IAM, OMS, xEVMPD
Scott Feiner, Clinical Trial Disclosure Specialist, AbbVie, USA
17:30 Q & A or Round Table Discussion
18:00 End of Pre-conference Workshop