On 21 September 2020, the European Medicines Agency (“EMA”) announced its plan to provide access to a test version of the Clinical Trials Information System (“CTIS”) by mid-2021. The CTIS results from the Clinical Trials Regulation (Regulation (EU) No 536/2014) which is anticipated to enter into application soon.
EU national competent authorities, drug companies, and ethics committees will have access to an isolated and secured testing environment of the CTIS, called “sandbox”. The EMA’s intention is to encourage potential users to familiarize themselves with the system before it goes live in December 2021.
Guidance concerning the access to the CTIS system and the submission of clinical trials applications
EMA has provided guidance concerning the following system features:
- All users will be required to self-register with the EMA’s Identity and Access Management (IAM) System.
- The EMA will validate accounts of high-level administrative users. These users include EU Member States, trial sponsors, and marketing authorisation applicants.
- For other users, the EMA will generate and send a one-time token to set up their accounts.
Concerning the submission of clinical trials application, the EMA has provided that:
- For applications that already have a sponsor administrator registered, applicants will need to ask the sponsor to assign them the role of “clinical trial administrator”. Otherwise, they will not be able to proceed with the application.
- Sponsor administrators will be able to assign users as clinical trial administrators for specific trials or for all trials of the company. All sponsors administrators will be in charge of amending, revoking, or approving user roles.
- Sponsor administrators will be free to assign as may users as they want. In this regard, the EMA reminded that the higher the number of users they assign, the more management tasks they will face.
Other clarifications provided by the EMA
The EMA has also provided guidance on other aspects of the coming CTIS. The use of wet signatures in clinical trials applications will depend on the national legislation of each EU Member State. Furthermore, companies will not be allowed to create user accounts for staff. This is because all users will have to self-register individually to get access to the CTIS.
The CTIS will generate notices and alerts to allow sponsors to have an overview of the clinical trial lifecycle. However, all information will remain within the system and no automated email alerts will be sent. For the moment, the CTIS will not address complex trial designs that involve the use of master protocols. Discussions in this regard have, however, already begun with stakeholders. Contrary to the practice in some EU Member States, there will be no naming convention for uploading the documents in the CTIS.
The EMA considers it unlikely that the UK regulator will have access to the CTIS, since the Clinical Trials Regulation is expected to enter into application after the leave of the UK of the EU. However, the EMA acknowledges that any later agreement could change this situation.
Warnings for users
As a general warning, the EMA invited users to carefully consider which members of their staff will have access to the CITS. A balance is required between the number of users needed in the system and the tasks related to clinical trials that must be performed. Failure to find this equilibrium could lead to an overburden of the system and jeopardize user management.
According to the EMA, preparation by users before using the test version is essential. In order to support this, the EMA intends to release other training materials to facilitate the use of the sandbox, such as quick guides, FAQs, and e-learning materials.
Authored by Elisabethann Wright and Silvia Lopez Arnao