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)...

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Hlavní autoři: Ene-Iordache, Bogdan, Carminati, Sergio, Antiga, Luca, Rubis, Nadia, Ruggenenti, Piero, Remuzzi, Giuseppe, Remuzzi, Andrea
Médium: Artigo
Jazyk:Inglês
Vydáno: American Medical Informatics Association 2009
Témata:
Original Investigation: Case Report
On-line přístup:https://ncbi.nlm.nih.gov/pmc/articles/PMC2732224/
https://ncbi.nlm.nih.gov/pubmed/19261946
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1197/jamia.M2787
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