Risk assessment and monitoring

It is important to understand risks to study integrity and to patients’ rights and wellbeing, and to check up on these risks during the course of each study.

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Click ‘Read More’, below, to see a summary of the recommendations in this section.

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Risk assessment and monitoring:

  • We recommend that routine study risk assessments include considerations about participation changes. In the pages of this section, we provide further detail in about what could be considered.
  • We also provide detailed recommendations around a) central monitoring of participation changes, b) monitoring of individual participation changes, c) responding to monitoring findings and d) monitoring planning.