The European Medicines Agency (EMA) will set up and maintain the portal and database, in collaboration with the Member States and the European Commission. 536/2014 is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information.
The Regulation will require: This will increase the efficiency of all trials in Europe with the greatest benefit for those conducted in multiple Member States.
It will also include the public registration of the clinical trial and any subsequent updates.
More precision of the delivery timeframe will be possible after a planned cycle of extensive testing by Member States and sponsor representatives and when further progress with the auditable version of the system has been made. EMA will provide further information on timelines after the audit.
The development remains aligned to the schedule that enables the EU Clinical Trial Regulation to come into application in the second half of 2019.
Ultimately, utilizing this baseline data helps sponsors determine indicators that assess clinical study quality and identify sites that are not performing optimally allowing clinical trial monitors to focus their time with the sites most in need of oversight.
The benefits of RBM include enhanced patient safety, improved trial oversight, more informed decisioning making, increased efficiencies across clinical trial operations, decreased costs for conducting clinical trials, and enhanced data integrity and compliance.
Risk-based monitoring (RBM) is the future direction for modernizing how clinical trials are conducted.