Data Capture from the Sponsors' and Investigators' Perspectives: Balancing Quality,Speed,and Cost

Abstract

Most clinical trials require the collection of enormous quantities of data at the clinical site. Traditionally, these data have been recorded on paper diary cards and case report forms (CRFs) and captured using double keystroke entry. Many factors in the drug development environment are now dictating that sponsors consider adopting new procedures for clinical data capture. This report compares and contrasts a variety of these techniques from the perspective of the sponsor and the investigative site. No single process is ideal for all studies. Indeed, it is important to select procedures to harvest clinical data that fit each study, individually, so that quality, speed, and cost can all be maximized. Clearly, quality must be the first consideration. Sponsors and contractors must also consider the investigative site to assure that these new data capture techniques can be implemented by the end user.