Design considerations when transitioning from paper case report forms (CRFS) to electronic data capture (EDC)

Background ICR-CTSU introduced EDC in 2012; this necessitated a revision of the systems and processes implemented for paper CRFs. Traditionally sites manually completed, signed and posted CRFs to ICR-CTSU. Once received, CRFs were tracked and transcribed onto the study database by a member of the ICR-CTSU trial team. Databases contained multiple complex validations to aid central data management. Data queries were raised by ICR-CTSU and sent to the sites by post. These processes had to be revised when EDC was introduced and alteration of CRF and database design was integral to this.