RESEARCH RESOURCES. The transitional period for the new EU legislation for clinical trials of medicinal products is coming to an end. For new applications the transitional period ended in January 2023. However, for ongoing trials registered in the EudraCT database the transitional period ends in January 2025. At that point, all current trials must either be completed or transferred to the Clinical Trial Information System (CTIS) database.
On January 31, 2022, the Clinical Trials Regulation (CTR) went into effect. CTR is a new EU regulation for clinical trials of medicinal products for human use (EU regulation no. 536/2014). It replaces national legislation and Directive 2001/20/EC on clinical trials of medicinal products. CTR came with three-year transitional rules that will end on January 31, 2025.
Contacts reserachers
The Sahlgrenska Academy Research Support Office will contact researchers who have trials registered in the EudraCT database that are not reported as completed. Trials that will be completed before January 31, 2025, must be reported before that date. Trials that will not be completed before January 31, 2025, must be transferred to CTIS. Regulatory authorities will prioritize the transfer of trials to reduce lead times, but it is the sponsor’s responsibility to complete the application for transfer on time.
Gothia Forum offer support to researchers to complete the transfer process from EudraCT to CTIS. To find more information on the services offered by Gothia Forum and contact information visit the Gothia Forum website.
For questions, please contact SA Research Support Office at: research.support@sahlgrenska.gu.se.
BY: SAHLGRENSKA ACADEMY RESEARCH SUPPORT OFFICE
