ABSTRACT

Electronic data capture (EDC) systems deliver clinical trial data from the investigation sites to the sponsor through electronic means rather than paper case report forms (CRFs). The site may be entering the information directly into screens without first writing it down on paper, in which case the record is an electronic source record. The site may first record the information on paper and then enter it later. The paper in this case may be normal site source documents or special worksheets provided by the sponsor; the paper is not a CRF and is not sent to the sponsor.