Protocol Deviation Log

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.

COVID-19 Protocol Deviation Note to File

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.

COVID-19 Note to File

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.

Consenting Hospitalized Patients by Phone or Video Conference

Guidance for Consenting Hospitalized Patients by Phone or Video Conference (DOC) 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 […]

Documentation of Written Informed Consent

For studies requiring written consent, the COVID-19 Documentation of Written Informed Consent (DOC) includes processes for when direct communications with participants is not feasible or safe due to COVID-19.

Documentation of Verbal Consent with LAR-PG

The Documentation of Verbal Consent with LAR-PG (DOC) is for use only in studies with an IRB-approved waiver of documentation of consent (no written signature required) but consent by a parent/legal guardian or Legally Authorized Representative is needed.

Documentation of Verbal Consent

The Documentation of Verbal Consent (DOC) is for use only in studies with an IRB-approved waiver of documentation of consent (no written signature required).