Table 2.

Modified trial activities

Trial activities	Before COVID-19	Revised in response to COVID-19
Trial assessments	Clinic appointments Phone calls	Telehealth appointments Phone calls
Consent	Clinic appointments	Telehealth appointments Phone calls and verbal consent Post/email consent forms
Patient surveys	Paper survey Email survey Electronic device	Phone calls Post/email survey
Investigational product	Hospital pharmacy dispensing	Home delivery
Training	On-site initiation meetings Videoconference	Videoconference Videoconference recordings available on demand
Meetings	Face to face Videoconference	Videoconference
Monitoring activities	Before COVID-19	Revised in response to COVID-19
Informed consent process	On-site visits	Remote monitoring visit phone calls Additional training and resources
Source data verification	On-site visits	Remote electronic medical record access Review administrative data sets
Data quality/trends	Remote data monitoring	Remote monitoring phone calls Remote data monitoring: - Focus on safety and outcome data - Data entry and query resolution timeframes relaxed during the peak of COVID-19 - Check COVID-19 protocol deviations
Essential document checks	On-site visits Electronic Trial Master File platform (limited use)	Written confirmation Electronic Trial Master File platform (wider use planned)
Monitoring checklists	On-site visit checklist	Remote monitoring visit phone call checklists