The following guidance is for implementing remote monitoring as a broad policy at the site level. In light of COVID-19, Veeva proposes that sites and sponsors take a risk-based approach to updating policies and study documents to include only critical elements needed in order to implement remote monitoring quickly while not introducing administrative burden on teams.
Policies and Documentation
As a trusted adviser and key partner, sponsors and CROs should advise sites on what is required to become “remote monitoring capable.” Generally speaking, sites and sponsors are remote monitoring capable when they have alignment across stakeholders, processes, and policies. When updating policies, sites and sponsors should understand the broadest regulations, policies, and expectations that apply, including the current thinking in light of COVID-19. Most importantly, sponsors and CROs should consider taking a risk-based approach when implementing remote monitoring for COVID-19 related trials to ensure patient safety while not adding administrative burden.
Existing regulations and policies should be referenced when applicable to ensure compliance is being upheld. Once understood, sites and sponsors can identify what they can control and implement (and what is required to be implemented now vs. later).
Sites and sponsors must ensure that the proper controls are in place across national regulations, clinical trial agreements, institutional policies, research informed consent forms, and internal SOPs.