Author: Danica

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.

Guidance for Consenting Hospitalized Patients by Phone or Video Conference (PDF) Please note this process should only be used for studies requiring written consent for hospitalized patients by phone or video conference for clinical trials while on isolation for confirmed or suspected COVID-19. This modified consent process must be reviewed and approved by the IRB prior to […]