The European Commission hopes to create a favorable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which will be going live at 31 January 2022. In the weeks before we will publish articles to help you prepare. In this article we provide an overview of the key considerations with regards to user management under CTR.
Introduction of the Clinical Trial Information System (CTIS)
The Clinical Trial Information System (CTIS) forms a single-entry portal for all clinical trials across Europe, requiring organizations to submit all documentation to the system from application to end-of-trial documentation. Employees, including commercial and non-commercial Sponsors as well as CROs, can have access to the CTIS to manage and execute clinical trials. Proper user management within the system is therefore imperative for completing all CTIS-based CTR activities. In addition, complex organizational structures can prove to be a challenge for user management under CTR and may require companies to reconsider their internal processes. Below we set out the different user roles and controls within the CTIS and the key considerations for companies to take into account.
Allocating Roles within CTIS
The roles with the most overarching rights are Admin roles, which consist of a Lead Sponsor Admin, a Clinical Trial Admin and a Market Authorization Admin.The latter is only relevant in cases of market authorization.
Admins have permission to:
- view all users sitting under an organization
- amend user roles (dates of authorization)
- assign and revoke roles.
As stated, Admins can determine the level of access an individual user has. There are three types of user roles: a viewer, preparer, and submitter role. The type of role determines their ability to perform certain functions. A viewer can only view documents, a preparer can create drafts and save them, and a submitter can submit the final document within CTIS. User roles are spread across the following process domains: Application, Notification, Safety, Results and the Clinical Study Report (CSR) (see Figure 1).
In addition to user roles, there are also three other levels of controls within the CTIS that can control access to process domains, including organizational level control, a time role, and a trial scope.
Approach of user management
The choice of approach to user management will depend on how an organization wants to operate. If an organization outsources many of the management activities, they may want to have more control over certain controls and access rights. Whereas an organization that has most management activities in-house may be able to opt for a simpler ‘admin approach’. The able below explaines the different approaches to user management within an organization.
User management in multi-affiliate and multi-CRO models
Organizations that have multi-affiliate models will face additional challenges with regards to user management as each affiliate will be given a separate organization ID, meaning that a user in one affiliate will have no rights in another affiliate. Each affiliate involved will therefore have to have separate Admin and User roles. A potential solution to this would be to create a single clinical trial center based in Europe through which all clinical trials are managed and executed (as mentioned in our previous article on legal representatives). However, if this is not a preferable option then companies with multi-affiliate models will need to consider the additional management challenges.
In addition, organizations with multi-CRO models also have certain challenges. Organizations with such models may need to consider limiting the access rights of CROs per clinical trial in order to ensure CROs do not have access to all documentation or documentation from other CROs involved.
User management is fundamental for, and will link to, all CTIS-based activities. It is therefore a major component of CTR compliance and something that organizations will need prepare for. One of the main CTIS-based activities is the submission of clinical trial applications. In the next blog we will zoom in on the submission strategies within CTR.
by Sebastian Payne
A Director at Deloitte, leading a team of Life Science specialists and focusing in Life Science Risk Advisory with over 20 years of experience in LSHC consultancy. Assisting organizations with insight and strategy delivery, in the face of significant Life Science regulatory and technological change.