EMA readies CTIS go-live plan
A new electronic information system for clinical trial reporting in the EU is one step closer to launch with the European Medicines Agency’s (EMA’s) Thursday publication of a go-live planning document.The 12-page document covers key steps remaining before the launch of the Clinical Trial Information System (CTIS), planned for 31 January 2022, and follows an April 2021 audit by EMA’s management board that confirmed that CTIS is “fully functional and meets the agreed functional specifications,” according to the planning document’s executive summary. (RELATED: EU clinical trial portal and database declared functional, Regulatory Focus 21 April 2021)
Priorities in getting ready for launch are to have the sponsor workspace fully functional; finishing the CTIS workspace for health authorities, and then, the public portal will follow. Also, EMA will stand up a dedicated service desk for CTIS issues as it also prepares materials for “extended stakeholder training.” (RELATED: CTIS set to launch in EU; sponsor guide now online, Regulatory Focus 02 August 2022)
The initial scope of CTIS activities will include clinical trial safety reporting and monitoring, and change management and other operational and procedural activities are centered around the support of those activities.
The eventual goal, according to the document, is to have communications related to clinical trial applications, reporting and supervision activities in the EU “supported by an EU portal and EU database which will ensure a single-entry point with a workflow with monitoring and decision-making by the relevant parties.”
CTIS is designed to have an application programming interface (API) that allows member states to access information contained in the database; most data submitted through the portal will be publicly accessible unless otherwise protected under the EU’s clinical trials regulation.
The project release plan that will take CTIS to its go-live date is supplemented by a detailed timeline for technical and infrastructure provisions, such as ensuring data protection, having a disaster recovery plan, and conducting ongoing system testing. This aspect of go-live planning also includes the transition from the current EudraCT system to CTIS.
Business operations planning includes, among other functions, a focus on member states preparedness; each member state should identify which organizations will be using CTIS and understand the business processes and users related to each CTIS function.
A major part of change management activities between now and the go-live date will be training, with separate training programs underway for each type of end user, from EMA internal stakeholders to member states, sponsors, and public portal users. EMA is employing a “train the trainer” model, with a suite of online tools available.
A communications plan is also incorporated into the change management aspect, with targeted communications also tailored to each different stakeholder group.
Finally, ongoing CTIS stakeholder engagement plans will carry through the go-live period, with a strong focus on engagement with member states and the regulatory network in the EU. Here, the master trainers who are training other end users will come together “to support the revision of the training materials and to provide a networking ground for those Member States experts engaged in providing or supporting CTIS training.”
EMA CTIS go-live plan
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