“Which patients have missed visits that may require “…specific information in the case report form that explains the basis of the missing data, including the relationship to COVID-19 for missing protocol-specified information (e.g., from missed study visits or study discontinuations due to COVID-19).
“Trial participants may not be able to come to the investigational site for protocol-specified visits,” allowing sponsors to evaluate “whether alternative methods for safety assessments (e.g., phone contact, virtual visit, alternative location for assessment, including local labs or imaging centers) could be implemented when necessary and feasible,”
“Trial participants who no longer have access to investigational product or the investigational site may need additional safety monitoring (e.g. withdrawal of an active investigational treatment)…
