As I observed here in January of 2020, “Developing complex portal applications with deep functionality is not easy, and addressing one challenge often lifts the lid on several new ones.”
What the CTIS Will Bring to Future Clinical Trials
Put simply, without the CTIS portal, EU 536/2014 cannot repeal the 2001 Directive. The portal enables the centralization, standardization, and harmonization that the 2014 regulations call for. It will act as a giant funnel for information and collaboration that sponsors, investigators, consultants, and nation states will be able to access. When complete, the portal will be the single entry point for clinical trial submissions in the EU, and will be used to manage all associated information, communication, workflows, and timelines.
When the CTIS portal is up and running, Regulation 536/2014 will apply to new trials, as well as previously existing trials that are still ongoing three years after the repeal of 2001/20/EC.
Some of the benefits of the CTIS portal include:
- Streamlined, harmonized electronic submission and assessment for clinical trials in multiple EU states
- Improved collaboration, information-sharing, and decision-making
- Increased transparency of information
- Highest standards of safety for all trial participants
Barring further delays, the CTIS portal should be available to investigators, sponsors, and patients after December 2021. For more information about the forthcoming transition, consult the EMA’s Questions & Answers.