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The Protocol Deviation Log (DOC) is intended to capture deviations across participants, allowing researchers to form a summary of overall Protocol Deviations caused by COVID-19.

The COVID-19 Protocol Deviation Note to File (DOC) is intended to be participant-specific, outlining the deviations that occurred for an individual participant due to COVID-19. A separate Protocol Deviation Note to File should be kept for each affected participant.

The COVID-19 Note to File (DOC) is intended to be a global Note to File, kept in a study’s regulatory binder, explaining COVID-19’s impact on the study overall.

The Documentation of Informed Consent with COVID-19 Participants – Impartial Witness form is required when an informed consent document cannot be collected by the study team due to COVID-19 isolation.