User management in the Clinical Trial Information System | Risk Advisory | Deloitte Netherlands

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User management in the Clinical Trial Information System

The European Commission hopes to create a favourable environment to conduct clinical trials in the EU with the implementation of the Clinical Trial Regulation (CTR), which is expected to go live at the beginning of 2022. In this blog we provide an overview of the key considerations with regards to user management under CTR.

By Paulien Nuyts and Sebastian Payne

Background

With the implementation of the Clinical Trial Regulation (CTR) (No 536/2014), the European Commission hopes to realise its ambition to create a favourable environment to conduct clinical trials within the EU. The CTR is the new regulation that governs all interventional clinical trials conducted in the EU with medicinal products for human use. CTR aims to harmonise submission and assessment processes, improve cooperation and transparency in and between Member States and enhance overall safety standards. In this series of blogs, we will examine the key changes and challenges faced and the potential competitive benefits for organisations that CTR introduces. In this third blog, we provide an overview of the key considerations around user management with the implementation of the new clinical trial information system (CTIS). Interested in our previous blogs CTR? Please read our first blog “Introduction to the Clinical Trial Regulation” and our second blog “Legal representation set out in the EU Clinical Trial Regulation.”

Legal representation set out in the EU Clinical Trial Regulation

Read blog 2 here

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 organisational 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 Authorisation Admin. The latter is only relevant in cases of market authorisation. Admins have permission to, 1) view all users sitting under an organisation, 2) amend user roles (dates of authorization) and 3) 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).

Figure 1. Overview of CTIS Sponsor Roles across process domains. ASR is Annual Safety Report.

In addition to user roles, there are also three other levels of controls within the CTIS that can control access to process domains, including organisational level control, a time role, and a trial scope.

Figure 2. All levels of control within the Clinical Trial Information System.

There are several approaches to applying user management within an organization, some examples are: 1) the admin approach, 2) a high-level domain user approach and 3) the deepest level of control approach (see Table 2).

How can Deloitte support you?

We have extensive experience in supporting regulators and top pharmaceutical companies to prepare for new Life Science Regulations, and since 2014 we have been helping organisations prepare for the implementation of the Clinical Trial Regulation. We are skilled with differentiating and setting up regulatory frameworks in challenging and diverse jurisdictions. We pride ourselves in supporting organisations in defining and executing optimal strategies for CTR implementation and ensuring they are and remain responsible businesses. Want to know more? Find our contact details below.

Table 2. Approaches to user management within an organisation.

The choice of approach to user management will depend on how an organisation wants to operate. If an organisation 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’.

User management in multi-affiliate and multi-CRO models

Organisations that have multi-affiliate models will face additional challenges with regards to user management as each affiliate will be given a separate organisation 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 centre based in Europe through which all clinical trials are managed and executed (as mentioned in our previous blog 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, organisations with multi-CRO models also have certain challenges. Organisations 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.

Final remarks

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 organisations 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.

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