1. Design considerations when transitioning from paper case report forms (CRFS) to electronic data capture (EDC)
- Author
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Leona M. Batten, Stephanie Burnett, James P Morden, Mark Webster-Smith, Emma Hall, Claire Snowdon, Charlotte Friend, Judith M Bliss, Sharon Ereira, Rebecca Lewis, Alexa Gillman, and Elizabeth Hill
- Subjects
Information retrieval ,Electronic data capture ,business.industry ,Data management ,Poster Presentation ,Medicine (miscellaneous) ,Medicine ,Pharmacology (medical) ,business ,CRFS ,Bioinformatics ,Database design - Abstract
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.
- Published
- 2015