Cerina - Risk Management Process

Accessing Cerina

Cerina strives to ensure a seamless and user-friendly registration process to minimize barriers for individuals seeking mental health support. Our registration process is designed to be straightforward and intuitive, reducing potential anxiety associated with seeking help for mental health issues. Upon accessing the app, users are provided with a clear explanation of our safety protocol, and their consent is required before proceeding further. 

What are the potentials risks?

As part of our commitment to being user safety, Cerina incorporates a robust risk assessment process to identify and mitigate potential risks. Users are guided through a screening process upon initial engagement with the app, which includes assessing mood and anxiety levels using standardized self-report measures such as the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) questionnaires. If a user's scores 10 or higher on PHQ-9, or 15 or higher on GAD-7, they are alerted that the app may not be suitable for their current needs and are encouraged to seek support from a mental health professional.

In instances where users report suicidal ideation during the screening process, Cerina signposts users to crisis support and resources provided within the app. Users are also encouraged to seek professional assistance tailored to their individual needs.

How the risk will be managed and by whom? 

The safety protocol is managed by the Cerina Executive Team, with the chief psychologist (Dr Momotaj Islam) taking the lead as the Clinical Safety Officer.  

Our safety protocol is evidence based and has been established (i.e. it has been tested in clinical trials) by the research and clinical teams in collaboration with our regulatory advisors. This is also in line with the evidence indicating the safety of the CBT based digital interventions for anxiety disorders.  

It is expected that the user may observe increased levels of anxiety whilst practicing some techniques requiring exposure and/or challenging their unhelpful thoughts suggested in the app. This is the case in both face-to-face therapy as it is in digital space. This is part of the therapy process, and the increased levels of anxiety symptoms often diminish over time once users get used to practicing those techniques in daily life.

If the user experiences difficulties with a particular therapeutic technique on the app and/or a technical problem, and would like to talk about it over the phone, they are advised to contact the Cerina support team on [email protected].

If the user experiences a distressing situation unrelated with Cerina they are advised to talk to their GP or other healthcare professional as appropriate.

Clinical Safety Governance Structure

Cerina's commitment to clinical safety is upheld by a dedicated Clinical Safety Governance Committee, led by our Chief Psychologist, Dr. Momotaj Islam, who serves as the Clinical Safety Officer. The committee comprises multidisciplinary experts from clinical, technical, and regulatory backgrounds, ensuring a comprehensive approach to safety management. Key members include Dr. Özlem Eylem-van Bergeijk, serving as the Research Lead, Priyadharshini Rajaram, our Technical Product Manager, and Vanisha Mistry-Ngumbau, our Regulatory Consultant. Regular meetings are convened to review safety protocols, assess emerging risks, and evaluate the effectiveness of mitigation strategies. This governance structure fosters collaboration and accountability, ensuring that clinical safety remains a top priority throughout Cerina's development and operation lifecycle.

Clinical Risk Management Techniques

1. Hazard Identification:


• Cerina employs proactive hazard identification techniques, such as the Structured What-If Technique (SWIFT), to systematically identify potential risks associated with the app functionalities and user interactions. These hazards encompass a wide range of clinical, technical, and operational scenarios, allowing for comprehensive risk coverage.
• Additionally, Cerina conducts timely hazard identification workshops and scenario-based exercises to solicit input from stakeholders and subject matter experts, enhancing the depth and breadth of hazard identification efforts.


2. Risk Analysis and Evaluation:


• Each identified hazard undergoes rigorous risk analysis and evaluation to assess its potential impact on user safety and the likelihood of occurrence. This analysis draws upon data collected from user interactions in the app (data is collected and processed in accordance with our privacy policy), clinical trials, and external research sources to inform decision-making.
• Risks are categorized based on severity and likelihood, allowing for prioritization of mitigation efforts and resource allocation to address the most critical safety concerns effectively.


3. Risk Control:


• Cerina implements a range of risk control measures aimed at reducing or eliminating identified hazards. These measures encompass both proactive interventions, such as app design enhancements.
• Risk control measures are regularly reviewed and updated in response to evolving clinical evidence, user feedback, and regulatory requirements to ensure ongoing effectiveness and relevance.


4. Documentation and Monitoring:


• Comprehensive documentation of hazard identification, risk analysis, and risk control activities is maintained through structured records, including a Hazard Log and Clinical Safety Case Report. These documents provide a transparent and auditable record of Cerina's safety management processes, facilitating regulatory compliance and stakeholder transparency.
• Timely monitoring and review mechanisms are in place to track the implementation and effectiveness of risk control measures, allowing for appropriate adjustments and refinements as needed.


5. Feedback Loop:


• Cerina fosters a culture of continuous improvement through an active feedback loop with users, clinicians, and other stakeholders. User feedback, incident reports, and safety-related data analytics are systematically analysed to identify emerging risks and opportunities for enhancement.
• Regular user engagement initiatives, such as surveys, focus groups, and usability testing, provide valuable insights into user experiences and perceptions of safety, informing iterative improvements to Cerina's risk management framework.

Safety Protocols and User Support

In addition to our proactive risk management efforts, Cerina offers robust user support mechanisms to address safety concerns and technical issues effectively. Users experiencing difficulties with specific therapeutic techniques or technical challenges are encouraged to contact our dedicated Cerina support team at [email protected] for prompt assistance. Furthermore, users encountering distressing situations unrelated to Cerina are advised to seek support from their general practitioner or other appropriate healthcare professionals, reinforcing our commitment to holistic user care and safety.