One of the primary goals of the new Clinical Trial Regulation (CTR), which went into effect in January 2022 and will become mandatory as of January 31st, 2023, is to streamline the process for multinational trials. A sponsor can now apply for authorizations in up to 30 EU/EEA countries with a single application that is submitted through CTR’s corresponding online portal, Clinical Trial Information System (CTIS). The good news for EU clinical trial submissions is that sponsors no longer need to submit applications separately to each country’s regulatory agencies for approval.
The not so good news is that the change is not merely limited to transitioning to a new submission portal. With implementation of CTIS, sponsors will need to transform processes in order to adapt to the new regulatory, compliance and transparency requirements that are part of the new regulation.
While change can be daunting at times, sponsors should view this as a unique opportunity to evaluate their current processes, adapt and upgrade their information systems and restructure operations to maintain compliance and prevent disruptions to new and ongoing clinical trials. In our blog series, we will highlight some of those challenges and offer recommendations on how best to address them.
1. ALIGN INTERNAL PROCESSES
Before everything else, sponsors should take the time to map out their own organization’s clinical trial submission processes. We realize that clinical trials processes can vary widely among different sponsors and trial types. Often the clinical teams and the regulatory teams work in silos, with each managing different documents and data related to the clinical trial. However, the new regulation might push sponsors to re-examine the value of this approach. The demands of CTIS submission will dictate a more collaborative workflow when it comes to managing clinical trials processes. The EMA has published a guidebook outlining different sponsor organization models and offering suggestions for how sponsors and their partners may organize for CTIS. Sponsors should map out clear accountabilities around tasks and around shared data and documents required for a clinical trial submission.
2. DEFINE CTIS RESPONSIBILITIES AND ASSIGN USER ROLES ACCORDINGLY
Once processes have been mapped, the next step would be to define CTIS responsibilities and user roles in the system. It is up to the sponsor to decide whether some or all organizations and individuals working on a clinical trial will need access to CTIS. To minimize user management burden and prevent any potential incidents, it is recommended that CTIS access be limited to a centralized and trained team that would handle document and data entry into CTIS. Resources should also be dedicated to monitoring CTIS for any alerts, Request for Information (RFI)s and communications from regulatory agencies. For instance, an RFI must be answered within 12 calendar days, or the application is lapsed. Efficient coordination of responses will be critical given the shorter timelines of the new regulation.
3. UTILIZE TECHNOLOGY TO MAXIMIZE EFFICIENCY AND MAINTAIN COMPLIANCE
The CTR/CTIS ushers a new era for clinical trial submissions in the EU. The goal of the new regulation is to streamline regulatory processes for sponsors. For that, sponsors will have to embrace technology that allows them to streamline cross-departmental workflow and maximize efficiency throughout the lifecycle of a clinical trial. Kivo’s solutions are designed specifically to help organizations achieve that. Kivo is set up to help facilitate hand offs and sharing of information and documents between teams efficiently, which will be critical for successful clinical trial submission in CTIS.
In our next blog we will examine the impact of CTIS on document management and how to meet compliance and transparency requirements of the new regulation.
Note: Since our webinar, the maximum document file size uploaded to CTIS has been updated from 10 MB to 50 MB.