Are alternate forms of visit appropriate?
Since trial participants may not be able to visit the site for the
protocol specific visits and investigations, sponsors should evaluate if
alternate measures such as virtual visits, alternate locations for
assessment, including imaging centers and labs, could suffice when
necessary, only after ensuring the safety of the participant. If an
in-person visit is necessary, it is the sponsors’ responsibility to
assure the implementation of the monitoring safely.(2,4) This is
important for trials that include participants who no longer have access
to IMPs and who need additional safety monitoring (eg. for withdrawal of
an active IMP).