Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with The Demand Trial  

Oleh:

Ene-Iordache, Bogdan ; Carminat, Sergio ; Antiga, Luca ; Rubis, Nadia

Jenis: Article from Journal - ilmiah internasional
Dalam koleksi: JAMIA ( Journal Of the American Medical Informatics Association ) vol. 16 no. 3 (May 2009), page 404-408.

Ketersediaan

Perpustakaan FK Nomor Panggil: J43.K.2009.02 Non-tandon: 1 (dapat dipinjam: 0) Tandon: tidak ada

Lihat Detail Induk

Isi artikel

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.

Opini Anda

Klik untuk menuliskan opini Anda tentang koleksi ini!

Kembali