Complying with the Clinical Trials Regulation: Guidance for sponsors
As part of the new Regulation, sponsors have new requirements to comply with. Sponsors should use the resources listed below to comply with the Regulation, which includes using CTIS.
Transition period ends 31 January 2025
Test
There has been a transition period for clinical trial sponsors to fully comply with the new regulation. This transition period ends on 31 January 2025. This means that all clinical trials approved under the previous Directive must now be recorded in CTIS.
Support for implementing the CTR
Sponsors can consult the resources published by the HPRA, the HMA and the European Commission. For CTIS resources, see the CTIS section below.
HPRA guide to conducting clinical trials in Ireland
The HPRA has compiled regulatory requirements for sponsors into a guidance document. Sponsors should use this document to help them comply with requirements for topics including:
- safety reporting
- supervision
- archiving
- appeals
- good clinical practice (GCP) inspections