Developing regulatory-compliant electronic case report forms for clinical trials: experience with the demand trial.
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.
Ene-Iordache
Bogdan
B
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
Carminati
Sergio
S
Antiga
Luca
L
Rubis
Nadia
N
Ruggenenti
Piero
P
Remuzzi
Giuseppe
G
Remuzzi
Andrea
A
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