Released June 24, 2020
Last updated: July 8, 2020
Because of the situation COVID-19 has presented us, there has been an increased need to ensure that we have clear explanations and documentation in the research record of protocol deviations and IRB-approved modified processes.
For information regarding monitoring, please see the Human Subjects Monitoring Guidance.
This toolkit has been designed to provide you with some templates that can be used to document protocol deviations, verbal consent processes, and written consent processes given the constraints of COVID-19. These documents should aid you in documenting this information in an efficient manner. They are intended to be downloaded and manipulated by researchers to fit their studies.
- 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).
- 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.
- 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 implementation.
- Please be sure to review the FDA’s guidance on the conduct of clinical trials of medical products during COVID-19 public health emergency.
- 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 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 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.
Please see HRPO’s reporting guidelines to determine appropriate reporting of protocol deviations.
For questions about best practices for documentation in the research record, please contact Andrea Morris, Manager of the Human Research Quality Assurance Program (HRQA), at 314-747-5525 or HRQA@wustl.edu.