CTIS go-live in January 2022 opens the three-year transition period. It is time enough to adapt to the new framework regarding the clinical trials documentation management in Europe, but there are several issues to be considered.
After the implementation of the platform, that shall take place on January 31st, 2022, the only ones obligated to begin using CTIS starting from the very first minute shall be the Member States. It should be taken into consideration that it is up to each Member State involved to determine which agencies must participate in the assessment of the application to conduct a clinical trial. Member States must also articulate the participation of the ethics committees within the authorization deadlines of clinical studies as established in the Regulation. Meaning we could say that the Member State is the entity that shall issue the joint assessment/authorization of the Regulatory Agency and Ethics Committee.
Three-year transition period for the sponsors
Sponsors will have a transition period of 3 years. Thus, the CTIS can be implemented in our organizations gradually during this transition period, so that the impact on the operations of sponsors and CROs can be distributed throughout this time.
Logically, this means that during the transition period, CTIS and EudraCT shall run in parallel, both being valid options when it comes to managing documentation and the submission of clinical trials in countries of the European Union, but we should consider other aspects such as:
- During the first year (starting 31/01/2022 until 31/01/2022), the request for new clinical trials can be made either through CTD as well as through CTR. The clinical trials that have been authorized under the CTD may continue under the CTD until the end of the 3-year transition period.
- For the ongoing clinical trials, the request for the transition of CTD to CTR shall be submitted well in advance in order to carry out a complete assessment before the end of the transition period, considering that in order to carry out the transition we must consider the study’s completion in all of the Member States as the end date. Meaning that, considering that the end of the transition period is on January 31st 2025, it is necessary to migrate the studies early enough in advance in order to carry out a complete assessment. Our recommendation is a minimum of 4-6 months, so that the Member States can issue clarifications (RFI).
Ultimately, if we have to submit a new study for it to be assessed, starting from 31/01/2022 and its end date in all Member States is after 31/01/2025, our recommendation is to submit it directly under the CTR, thus via CTIS. In this manner, we shall avoid following migrations and new assessments and workload. Furthermore, a migration strategy must be considered for all ongoing studies that conclude beyond the transition period in all Member States.
When does a clinical study change from CTD to CTR, meaning to CTIS?
But what conditions should there be in order to change the regulatory framework governing a clinical study? Meaning, when to change from CTD to CTR?
We must consider two premises:
- Trials that currently aren’t subject to any ongoing assessment process under the Directive in none of the countries of the European Union.
- Trials with a harmonized protocol in all the Member States.
In order not to suffer any unwanted delays, we must consider that, if premise number 2 is not met, a substantial amendment must be submitted to all Member States under the current directive (CTD), to harmonize the protocol and assure its compliance under the new Regulation (CTR). As always, the responsibility regarding the compliance under the CTIS, therefore, within the CTR parameters, falls upon the clinical study’s sponsor.