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Conduct a risk assessment to minimise the impact of challenges on trial success.
A risk assessment for a clinical trial involves identifying and evaluating potential risks to the trial. These risks are then addressed and mitigated to ensure trial results are accurate.
A risk assessment is focused on identifying different factors that may alter the results of a clinical trial. Points of consideration include anything that may affect participant safety, data integrity, regulatory compliance or trial success. It is important to check if your relevant sponsor or institution has any other risk assessment requirements.
The potential impact of different factors is then evaluated to mitigate their effect on the trial. By recording these factors, researchers make their work more reproducible, protecting its validity.
Here are some of the tasks you’ll need to complete during your risk assessment:
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