Most major clinical trials today utilize electronic data capture (EDC) systems, which
are configured to handle the specific requirements of a trial’s protocol and provide
clinical sites with a computerized system for data entry. However, many clinical
studies today are changed mid-stream—during the time when patient data is being
captured and entered—because of modifications in research design, regulatory
questions or other developments. Such modifications can require data entry to be
halted while the trial administrator rewrites the computerized case report forms and
moves data previously collected.