Please see additional guidance regarding the regarding the creation of a COVID-19 Form.
Question: From the standpoint of the NCI, do the LPOs need to collect detailed information about the deviation due to COVID-19 on our COVID-19 form(s)? Examples include travel related, positive diagnosis and physician decision.
NCI Response:
- Per the Memorandum on Additional Guidance for Clinical Trial Activities Affected by The Novel Coronavirus 3-23-2020: “These minor deviations would need to be documented in the medical record by the Responsible Investigator with the reason for the deviation (e.g., mandatory or precautionary travel restrictions to prevent exposure to the virus) and brief justification for why the deviation was considered to be minor (e.g., routine follow-up on patient no longer on active therapy).
- Although NOT specifically specified in the memorandum it would be best practice, especially for IND studies, to include a question regarding the root cause (ex. travel related, positive diagnosis, physician decision) of the event in your Rave COVID-19 protocol deviation forms.
