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We have a general risk report for each study and are filing that as a sub artifact at the Core level under 01.01.16 Risk Management Plan. Our Veeva Vault administrator added a sub artifact 01.01.16.01 COVID-19 reports. But where should we be filing COVID-19 related documents? Such as letters to each site, Site level document, general correspondence? Or should we create one main sub artifact for all CIVID-19 documentations? And at what level, Core for all those docs to have them in one location regardless of the topic? Thank you
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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.
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