The introduction of the Clinical Trials Regulation will also see the introduction of the new Clinical Trial Information System (CTIS) which will act as a single entry point for submitting clinical trial information in the EU and will support the daily business processes of Member States and sponsors throughout the life cycle of a trial. Additionally, the CTIS will also assist in making clinical trial information in Europe more accessible and transparent.
In anticipation of the introduction of the CTR, and the launch of CTIS, the following training has been organised by the EMA:
Dedicated training webinars detailing essential information on CTIS for micro, small and medium-sized enterprises (SMEs) and non-commercial (academic) sponsors
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 1 (22 February 2021) The first training session will provide an overview of CTIS, user access management (including how to register users), sponsor user management and sponsor roles and permissions in CTIS.
- SME and academia Clinical Trials Information System (CTIS) two-part training webinar: Day 2 (4 March 2021) The second training session will cover submitting an initial trial application in CTIS, updating an initial trial application and making substantial modifications along with adding a concerned Member State, making non-substantial modifications and submitting trial results.
It is recommended that participants attend both training dates and a video of the webinar will be published by the EMA after the event.
While this is a general webinar, it will provide relevant information to sponsor organisations that will be using CTIS in future.
- 3 February 2021 (2pm – 4pm): Introduction to OMS services and activities including change request process, customer service desk and data quality management.
- 4 February 2021 (2pm – 4pm): Introduction to RMS services and activities including change request process.
To join the webinar, please use this link.
For queries on the above webinars, please contact email@example.com.
EMA CTIS Master Trainers’ Training Programme for sponsors
To support the launch of the CTIS the EMA have prepared a CTIS Master Trainers’ Programme which will start in the second quarter of 2021.
The Programme is primarily intended, and due to its extent is suitable, for commercial sponsors from the Pharmaceutical Industry and Contract Research Organisations (CROs) that are likely to submit several clinical trial applications, and that will have many users with different CTIS user profiles within the organisation.
The CTIS Master Trainers Programme consists of 3 parts:
- Part I: 3 half days training on Essentials for CTIS users.
- Part II: 4 half days training on the clinical trial application process and the specific CTIS user roles available for sponsors.
- Train the Trainers: 1 to 2 half days on training design, training delivery and facilitation.
During the first applications period, a maximum of one person per organisation will be eligible to apply. After this date, any remaining slots will be open and eligible organisations can opt to send in more applications. The applications period will close once the programme is full.
- Deadline for the 1st applications’ period: 16 February 2021
- Selection announced: 8 March 2021
- Opening of the 2nd applications’ period: 8 March 2021
For any questions related the fees and registration to the CTIS Sponsor Master Trainers Programme, please contact firstname.lastname@example.org.
Further information regarding upcoming EMA events and CTIS training can be located on the EMA News and Events and CTIS highlights pages. An EMA organised CTIS webinar on the ‘dynamic demo of sponsor workspace’ was also held in September 2020 and can be located here.
(Information provided by the European Medicines Agency and also available on the HPRA website)