Table 3 Working example of monitoring using phone and video conferencing

1

Decrease the requirement for site-level monitoring; by implementing alternative monitoring mitigations

TC or email site staff (PI team) to ask if/when they are available for a TC or VC in place of an on-site monitoring visit and what data could be shared with the monitor ahead of this virtual meeting.

Use video conferencing if the site has the IT access. If not, then a TC. Ensure monitors have the flexibility to meet with site staff when it is convenient for the sites.

2

Prioritise patient safety, outstanding site actions and data integrity of the study primary endpoint for remote monitoring

Develop a template tracker to ensure the minimum safety and primary endpoint data are discussed in the TC/VC.

Put the questions in priority order for the TC/VC.

3

Give the site as much time as possible to prepare*

Request appropriate documents ahead of the meeting—keep this to a critical minimum.

This could include investigator site files (ISFs); delegation logs; primary endpoint pseudonymised source data.

4

Conduct a successful site TC/VC.

Review appropriate documents ahead of the meeting.

In line with preparation for all monitoring visit types

5

Prioritise the discussion with the site in case the call is cut short by technical problems or a local emergency.

Use the template tracker completed with all actions required of the site and prioritise the TC/VC discussion accordingly.

Discuss the timing of the next remote visit

6

Manage any resulting issues

Escalate any unreported SAEs, missing visits, major deviations impact on patient safety/data integrity of missing visits.

Quality, CI, PI, stats and sponsor may need to be consulted.

Update study risk assessment with site-specific issues and/or availability during COVID-19 outbreak. Consider what appropriate actions, if necessary, should be undertaken

7

Complete the monitoring visit report (MVR) and site f/up letter.

As normal.

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