Clinical Research and GCP Update

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You should have done a risk assessment for each trial • Consider the impact on each of your trials̶ prioritise critical tasks for each trial • Look at the existing risk assessments and build in relevant changes • Focus on:̶ human subject protection̶ data integrity • When the two conflict human subject protection comes first • Regularly review and re-assess the risks • Document everything ̶ because this will be needed post-pandemic!

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Specific risk considerations may include …

Data integrity • Oversight maintenance • Remote data capture • Move to centralized monitoring • Missing data • Source data verification • Monitoring plan for now and later • Amendment of data management plans • Statistical analysis plans • What is and is not related to COVID-19?

Human subject protection • Continuation or discontinuation of IMP or trial • Visits to investigator site • Contact with ‘people’ • Safety of IMP if not monitored • Self medication • Procedures to obtain and deal with safety data • Additional safety monitoring if IMP is withdrawn • Engage with IRB/IEC as soon as possible (if possible)

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© Brookwood Global (Canary Ltd) 2021

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