Table 2 Modified trial activities
From: Conducting clinical trials during the COVID-19 pandemic—a collaborative trial network response
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 |