Clinical Research and GCP Update

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Identify risks

• The sponsor should identify risks to critical trial processes and data. • The risk assessment process should start at the time of designing the study and writing the protocol. • Risks should be considered at ̶ system level (e.g., standard operating procedures, computerized systems, personnel) ̶ clinical trial level (e.g., trial design, data collection, privacy and data protection, informed consent process). • It is important that an ongoing appraisal of

actual risks is undertaken whilst the study is ongoing. The sources of information required to do this need to be identified.

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Monitor areas of concern

• You must have measures in place to be able to detect non-compliance and monitor your identified risks. • What should be done if non-compliance is detected?

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