Clinical Research and GCP Update

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Post-pandemic measures planning

• It is essential that robust follow-up measures are planned and ready to be implemented when the situation is normalised. • This should include increased on-site monitoring for a period that is sufficient to ensure that the impact of the reduced monitoring can be rectified, and problems resolved or properly documented. • Data subject to remote source data verification are likely to require re-monitoring̶ in particular if it was based on pseudonymised documents, which cannot be considered as source documents, ̶ remote monitoring is expected to only have focused on the most critical information

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Documented post-pandemic plan

• Some countries and regions will return to normality before others. • A plan is therefore required for each centre within a country, together with an overall plan. • This should be based on a risk assessment and critical to quality factors identified.

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© Brookwood Global (Canary Ltd) 2021

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