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Table 3 Working example of monitoring using phone and video conferencing

From: Monitoring advances including consent: learning from COVID-19 trials and other trials running in UKCRC registered clinical trials units during the pandemic

Action item Aim Monitor’s actions Comments
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. No comments.
  1. TC teleconference, VC video conference, CI chief investigator, PI principal investigator, SAE serious adverse event
  2. *Note that for COVID-19 studies, sites should be informed of and agree to the minimum data they will be asked to supply for remote monitoring, where employed