Understanding and implementing the EU CTR 536
The aim of this course is to provide an overview of the Clinical Trial Regulation 536/2014 (CTR) and to allow participants to implement it in their organisations. It will allow participants to understand how the Clinical Trials Information System (CTIS) is set up, in 4 modules.
The European Clinical Trial Regulation (CTR) 536/2014 is the legislation that harmonises regulatory processes and information on interventional clinical trials in Europe. To meet CTR requirements, entries in the European Clinical Trials Information System (CTIS) are mandatory. Once the CTIS is launched (planned for 31 January 2022), it will be operational and the implementation of the CTR can start. All stakeholders need to know how to work according to the new rules (CTR) and use the CTIS. This course aims to provide an overview of mandatory CTR requirements and allow participants ready to implement them and be compliant with them.
The 4 modules are:
Module 1: CTR and CTIS fundamentals
Module 2: Preparing for submission of a clinical trial
Module 3: Submitting the Initial clinical trial application
Module 4: Submissions during an ongoing clinical trial