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On July 31, 2021, the European Commission announced the full functionality of the EU portal and database, the Clinical Trials Information System (CTIS) in the Official Journal of the European Union. The CTIS is inextricably linked with the Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use. The EU portal and database will go-live on January 31, 2022 and the Regulation will also enter into force on that date. The CTIS will be a single entry point for clinical trials submission, authorisation and supervision in the EU. It will improve cooperation and communication between sponsors and authorities, and will increase the transparency of clinical trials by partially making public of the documentation and data from clinical trials. The access and functionality of the CTIS will be different for authorities workspaces, sponsors workspaces and general public workspaces.

The CTIS will be connected with other data bases and systems such as:

• User Registration and Roles (IAM) – user registration system that provides the access to EMA applications
• Data Warehouse/Data Intelligence (DWH) – which enables to obtain reports and statistics from the CTIS
• Document management (SharePoint) – a central repository for documents that supports to upload and view documents
• Organization Management Service (OMS) – organisations’ database
• EudraVigilance -Medicinal Product Dictionary (XEVMPD) – which provides data on medicinal products

The functionality of the CTIS is to provide the sponsor with efficient management of clinical trial data necessary for the authorization and supervision by authorities. Sponsor workspace provides functionalities that support preparation, compilation and submission of data. The first functionality in the CTIS available for sponsors will be “Clinical trials” overview, which will store the information about clinical trials or applications. Also, in the CTIS sponsors can find functionality “Notices & alerts”. Notices will inform user about the event connected with a clinical trial and alerts will inform users of an action that needs to be taken by them regarding a clinical trial. Another important tab in the CTIS in the sponsor workspace is “Annual safety reporting”, which will allow for submission of annual reports and the safety status of the investigational medicinal product (IMP). The fourth functionality available for sponsors is “User administration”, which will be visible only for certain users, who have administrator roles, which allows them to manage the users registered in the system and assign them roles and permissions. The tab “RFI” (request for information) is connected with the oncoming requests from authorities for additional information from sponsors.

It is the sponsor who decides whether some or all organizations and individuals working on a clinical trial will have access to the CTIS. The users must first self-register in EMA Account Management Portal (IAM) to access CTIS. Registered users have limited activity, unless an additional activity is granted by the administrator. The CTIS enables users to perform actions depending on the permissions  attached to their user role(s). Among the roles we can distinguish administrator roles (such as Sponsor administrator, CT Administrator) or business roles (perform specific roles in the CTIS such as preparer, submitter etc.). As it was stated particular roles have specific permissions assigned to them, which define the actions that can be performed in CTIS. The permissions can be divided into Business permission (e.g. create considerations, create annual reports, create responses to RFI) and Access permissions (such as view, prepare and submit).

Before submission of application for the authorization sponsor should consider whether organization-centric approach or trial-centric approach model of access to CTIS would be suitable. In an organization-oriented approach, a high-level administrator role (previously validated by EMA, registered in IAM) is required to manage other users. Creating a high‑level administrator role automatically places the organization in an organization-oriented approach. In this approach high-level administrators or mid-level administrators will assign roles to users in all clinical trials or in a specific clinical trial that the organization manages. This approach is intended for big organisations.

In the trial-centric approach to submit the application and manage the trials there is no need to create a high-level administrator role validated by EMA and registered in IAM. Any registered in IAM sponsor’s user can create an initial clinical trial application. In that case, the user will be automatically assigned as the CT administrator for that specific trial. This approach is intended for organisations with a small number of users and which manage few applications/clinical (especially for non-commercial sponsors).

When assigning roles to users, sponsors should carefully consider the scope of data that users will be able to view and edit. CT administrator has all business sponsor roles which means that he can view and edit the IMPD-Q (Investigational Medicinal Product Dossier- Quality). Thus, it is important for the sponsors whether to assign this role within their company or to delegate to CRO, in which case confidentiality arrangements may be needed. Moreover, a sponsor may limit access to IMPD-Qs by cross-referencing to an IMPD-Q in an existing trial where appropriate. If the other roles are assigned by the administrators, users with Q-IMPD Viewer role can view this document and users with Q-IMPD Preparer role, can view and change this document. However, a user with an Application submitter role, who has also the viewers’ and preparers’ permissions, cannot create IMPD-Q.

The new EU portal and database provide new opportunities for sponsors to apply for the authorization of a clinical trial or provide data necessary for the supervision of clinical trials by authorities. Before starting the work in the CTIS, a sponsor should consider what access to the CTIS is to be given to other organizations with which it intends to cooperate in this CRO. The sponsor should consider whether the cooperation with the CRO should take place outside of the CTIS, i.e. the CRO prepares the documentation and the sponsor himself submits it to the system, or whether he should grant some or even all of the authorizations to view, prepare and submit documents.

Based on many years of experience, the Clinmark team is able to advise on the selection of the appropriate data management strategy in the CTIS. Moreover, diligent experts can directly support the preparation and submission of documents to the CTIS. Do not hesitate to reach out to find out more about our services.