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This is an individual sponsor decision but my inclination would be to avoid updating a TMF structure specifically for COVID-19. This is certainly a significant risk currently but I’m not seeing a justification for classifying the documents in a different way to how they would ordinarily be classified. If you need a means of quickly identifying all COVID-19 related documents for a study, you can use a naming convention and/or search capabilities to achieve this. Letters to a site that concern action you’ve taken with regards to COVID-19 should be processed and filed in the same way as for any other site communication. Whilst this is an extraordinary situation, we do not create filing exceptions for any other clinical trial risks.