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).