By: ABRS- Academic Team
Introduction
Annual safety reporting is a well-established sponsor responsibility in European clinical trials, but the way these reports are submitted and managed in the Clinical Trials Information System (CTIS) has now changed. According to the European Medicines Agency’s Sponsor Guidance for the New Safety Module on the Annual Safety Report, the new Safety Module was introduced into the CTIS Sponsor Workspace on 28 September 2026, and all new Annual Safety Reports (ASRs) must now be submitted through this functionality. EMA Sponsor Guidance: New Safety Module on the Annual Safety Report European Medicines Agency
For clinical teams, the change is not only about navigating a different area of CTIS. It also requires sponsors to understand how existing submissions are handled during the transition and which workflows apply to new reports. EMA indicates that the previous Annual Safety Report tab will remain available for two months so that Member States can complete assessments already underway and sponsors can continue accessing related Requests for Information through the previous functionality. European Medicines Agency
Preparing for the new workflow therefore involves more than system access. Safety, regulatory, and clinical operations teams need a shared understanding of responsibilities, submission pathways, and how information should move between functions when an ASR or related request requires action. EMA has also provided dedicated training and support materials to help sponsor organizations prepare for the new module. EMA CTIS Training and Support European Medicines Agency This blog examines what the new workflow changes, why cross-functional coordination matters, and how clinical teams can maintain continuity during the transition.
What the New ASR Workflow Changes
The new CTIS Safety Module changes how sponsors create, submit, and manage Annual Safety Reports within the system, but it does not create a new annual reporting obligation. That obligation is already established under Article 43 of Regulation (EU) No 536/2014, which requires sponsors to submit an annual safety report to the European Medicines Agency for investigational medicinal products, other than placebo, used in clinical trials for which they are responsible. Regulation (EU) No 536/2014, Article 43 Eur-Lex
What has changed is the submission pathway. According to EMA’s updated sponsor guidance, as of 28 September 2026, all new ASRs must be submitted through the new Safety Module in the CTIS Sponsor Workspace. At the same time, creation of new ASRs through the previous Annual Safety Report functionality is disabled. This means clinical and safety teams need to ensure that future submissions are initiated through the correct CTIS workflow rather than relying on processes used before the module’s go-live. EMA Sponsor Guidance: New Safety Module on the Annual Safety Report European Medicines Agency
EMA has also established a two-month transition period for ASRs that were already being assessed through the previous functionality. During this period, those ongoing assessments can continue through the old pathway, and sponsors can still respond to related Requests for Information. The former Annual Safety Report functionality is expected to remain available for these purposes until 28 November 2026, after which the transition is planned to end. EMA guidance on ASR transition arrangements European Medicines Agency
From an operational perspective, this temporary overlap creates two possible pathways that teams may need to distinguish: new ASRs moving through the new Safety Module and previously submitted ASRs completing assessment through the former functionality. Maintaining clarity about which workflow applies to each report can help safety, regulatory, and clinical operations teams coordinate responsibilities and avoid treating the transition as a simple system update. The broader challenge is ensuring that the people involved understand where an ASR sits in the process, where related communications should be managed, and who is responsible for the next action.
Why Roles and Cross-Functional Coordination Matter
The new Safety Module introduces role-specific access that directly affects who can manage Annual Safety Reporting activities in CTIS. According to EMA’s Sponsor Guidance: New Safety Module on the Annual Safety Report, the ASR Submitter is the business role responsible for Annual Safety Reporting activities within the module, while the Sponsor Safety Admin manages safety-related role assignments. Importantly, administrative access does not automatically provide permission to perform ASR business activities, making it necessary for sponsor organizations to confirm that responsibilities and system permissions are aligned before a submission or response is required. European Medicines Agency
Access also depends on the scope assigned to the ASR Submitter role. EMA explains that users may be authorized for all trials or for specific trials, and their level of access to an ASR is determined by whether the clinical trials included in that report fall within their assigned scope. Full access to the submission, RFI, and summary and conclusion areas requires the user’s authorized scope to cover all trials included in the ASR. This makes role configuration an operational consideration rather than simply an administrative setup task. European Medicines Agency
The transition period adds another layer of coordination. EMA specifies that role assignments in the legacy Clinical Trial area and the new Safety area are not synchronized during this period. A user who needs to work in both environments must therefore hold the appropriate role in each. EMA guidance on the new ASR workflow and user roles This is particularly relevant for teams managing new ASRs in the Safety Module while continuing to follow an older report or RFI through the previous functionality. European Medicines Agency
From an operational perspective, these permissions make cross-functional coordination especially important. The person authorized to submit or respond in CTIS may depend on safety, regulatory, clinical operations, or other internal stakeholders to prepare and review the underlying information. EMA also notes that the ASR Submitter receives notifications when an RFI is raised and is the role permitted to view and respond to that RFI in the new module. Establishing in advance who monitors these communications, who coordinates the response, and who is authorized to act in CTIS can help teams manage the workflow without confusing system permissions with broader functional responsibilities.
Maintaining Continuity During the Transition
The transition to the new Safety Module requires sponsors to manage both current and legacy Annual Safety Report activities without losing visibility over reports already in progress. According to EMA’s updated Sponsor Guidance for the New Safety Module, the previous ASR functionality remains available temporarily so that assessments already underway can continue while new ASRs move through the new Safety Module. This parallel period makes it important for teams to distinguish clearly between reports following the legacy workflow and those initiated in the new environment. European Medicines Agency
Continuity also involves preserving access to information before the legacy functionality is retired. EMA advises sponsor users to download relevant ASR submissions, Requests for Information, and RFI responses for assessments that remain incomplete at the end of the transition period. Those unfinished assessments will not be transferred into the new Safety Module; instead, they will need to be completed outside the new ASR workflow under arrangements managed by the relevant Safety Assessing Member State or Reporting Member State. European Medicines Agency
For clinical teams, this means that transition planning should extend beyond learning a new CTIS interface. Teams may need to identify which reports remain active in the previous workflow, confirm who retains the necessary access, preserve relevant documentation, and maintain clear ownership of outstanding actions. At the same time, users responsible for new ASRs need the appropriate roles and scope within the new Safety Module. EMA’s CTIS training and support resources provide dedicated guidance and training materials to help sponsor organizations prepare for these operational changes. European Medicines Agency
A structured transition can help reduce uncertainty when responsibilities, systems, and reporting pathways temporarily overlap. For sponsors, the practical objective is continuity: knowing where each ASR is being managed, who is responsible for the next action, and how relevant records and communications will remain accessible as the legacy workflow is phased out. This approach supports consistent coordination across safety, regulatory, and clinical operations teams while the new CTIS process becomes established.
Conclusion:
The transition to the new CTIS Safety Module is more than a change in where Annual Safety Reports are submitted. EMA’s updated sponsor guidance sets out a new operational pathway for ASRs from 28 September 2026, alongside a temporary transition period for reports already being handled through the previous functionality. European Medicines Agency
For sponsor organizations, readiness therefore depends on maintaining visibility across both systems and responsibilities. Teams need to understand which workflow applies to each report, ensure that the appropriate users have the required CTIS roles and scope, and maintain clear ownership of submissions, Requests for Information, and outstanding actions. EMA’s dedicated training and support resources reinforce the importance of preparing users for the new functionality and understanding how it fits within existing CTIS processes. European Medicines Agency
The broader operational lesson is one of coordination. Safety reporting may involve specialized regulatory and pharmacovigilance responsibilities, but successful execution also depends on information moving effectively between the functions supporting the trial. During a system transition, clearly defined roles, accessible records, and established communication pathways can help preserve continuity while teams adapt to the new workflow.
As sponsors incorporate the new Safety Module into their processes, the priority should be to align system access, functional responsibilities, and cross-functional communication so that Annual Safety Reporting remains visible and manageable throughout the transition.
