Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with The Demand Trial
- Bogdan Ene-Iordachea,
- Sergio Carminatia,
- Luca Antigaa,
- Nadia Rubisa,
- Piero Ruggenentia,b,
- Giuseppe Remuzzia,b,
- Andrea Remuzzia,c
- aClinical Research Center for Rare Diseases, Aldo e Cele Daccò, Mario Negri Institute for Pharmacological Research, Ranica (BG), Italy
- bUnit of Nephrology, Azienda Ospedaliera Ospedali Riuniti, Bergamo (BG), Italy
- cDepartment of Industrial Engineering, Università di Bergamo, Dalmine (BG), Italy
- Correspondence: Bogdan Ene-Iordache, EngD, Laboratory of Biomedical Technologies, Clinical Research Center for Rare Diseases Aldo e Cele Dacò, Via G.B. Camozzi 3, 24020 Ranica (BG), Italy; e-mail: <bodgan{at}marionegri.it>
- Received 12 March 2008
- Accepted 31 January 2009
Abstract
The use of electronic case report forms (CRF) to gather data in randomized clinical trials has grown to progressively replace paper-based forms. Computerized form designs must ensure the same data quality expected of paper CRF, by following Good Clinical Practice rules. Electronic data capture (EDC) tools must also comply with applicable statutory and regulatory requirements. Here the authors focus on the development of computerized systems for clinical trials implementing FDA and EU recommendations and regulations, and describe a laptop-based electronic CRF used in a randomized, multicenter clinical trial.
