title: Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial.
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.
authors.affiliation: Laboratory of Biomedical Technologies, Clinical Research Center for Rare Diseases Aldo e Cele Dacò, Via G.B. Camozzi 3, 24020 Ranica (BG), Italy. bodgan@marionegri.it
authors.forename: Bogdan
authors.initials: B
authors.lastname: Ene-Iordache
authors.forename: Sergio
authors.initials: S
authors.lastname: Carminati
authors.forename: Luca
authors.initials: L
authors.lastname: Antiga
authors.forename: Nadia
authors.initials: N
authors.lastname: Rubis
authors.forename: Piero
authors.initials: P
authors.lastname: Ruggenenti
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Remuzzi
authors.forename: Andrea
authors.initials: A
authors.lastname: Remuzzi
mesh_terms: D003199:Computer Systems; D016208:Databases, Factual / Q000592:standards; D005062:European Union; D033161:Government Regulation; D016247:Information Storage and Retrieval / Q000592:standards*; D016347:Medical Records Systems, Computerized / Q000592:standards*; D016032:Randomized Controlled Trials as Topic / Q000592:standards*; D014481:United States; D014584:User-Computer Interface