Risk assessment

Overview

Risk assessment is a crucial component of any trial, helping SMEs identify potential challenges and develop strategies to mitigate them. It involves evaluating factors that could be a barrier to the success of the trial, both from a technical and operational standpoint. This section addresses risk identification, impact assessment, probability evaluation, ownership allocation, and strategic mitigation planning to ensure a resilient approach throughout the trial. Effective risk mitigation ensures that the trial progresses smoothly, and issues are proactively addressed.

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Questions and prompts

Within your trial plan, it will be useful to detail the following:

Risk identification: what are the potential risks associated with the trial?

Consider technical, operational, and external factors that may pose challenges. Examples include technology malfunctions, data security breaches, regulatory changes, or community resistance.

Risk impact: what would be the impact of each identified risk on the trial's objectives and success criteria?

• Evaluate the potential consequences of each risk, considering factors such as project timeline, budget, stakeholder relations, and the overall effectiveness of the technology.

Probability assessment: how likely is each identified risk to occur?

Assign a probability rating to each risk, considering historical data, expert opinions, and any relevant information available. This helps prioritise high-impact, high-probability risks.

Risk owner: who owns each identified risk, and what are their responsibilities?

Clearly define roles and responsibilities for risk management. Assign specific individuals or teams to take ownership of particular risks and outline the actions they are responsible for.

Mitigation: what strategies will be employed to mitigate or manage each identified risk?

Develop specific mitigation plans for each risk, considering preventive measures, contingency plans, and response strategies. This may involve adjusting project timelines, enhancing security measures, or creating backup solutions.

To support you in answering the above question(s), please find a link to the 'project risk management' diagram below that can be downloaded in both PPT and JPEG and used within your trial plan.

Risk Assessment

2MB

Risk Assessment - Template.pptx

Dependencies and Assumptions

2MB

Dependencies and Assumptions - Template.pptx