Computerized Systems Used In Clinical Trials

<h2 id="external-links">External links</h2>
<ul><li><a href="https://www.fda.gov/regulatoryinformation/guidances/ucm126402.htm">Text of the guidance</a></li></ul>

<h2 id="references">References</h2>

<ol>
<li id="fn:1"><p>Singer, Donald C. (2001). A Laboratory Quality Handbook of Best Practices. ASQ Quality Press. pp. 40–48. ISBN 9780873894913. <a href="9780873894913" target="_blank">9780873894913</a> <a href="#fnref:1" class="footnote-back-ref">↩</a></p></li>
<li id="fn:2"><p>Ene-Iordache, B.; Carminati, S.; Antiga, L.; Rubis, N.; Ruggenenti, P.; Remuzzi, G.; Remuzzi, A. (2009). "Developing Regulatory-compliant Electronic Case Report Forms for Clinical Trials: Experience with the Demand Trial". Journal of the American Medical Informatics Association. 16 (3): 404–408. doi:10.1197/jamia.M2787. PMC 2732224. PMID 19261946. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732224" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2732224</a> <a href="#fnref:2" class="footnote-back-ref">↩</a></p></li>
<li id="fn:3"><p>Ohmann, C.; Kuchinke, W.; Canham, S.; Lauritsen, J.; Salas, N.; Schade-Brittinger, C.; Wittenberg, M.; McPherson, G.; McCourt, J.; Gueyffier, F.; Lorimer, A.; Torres, F. N.; ECRIN Working Group on Data Centres (2011). "Standard requirements for GCP-compliant data management in multinational clinical trials". Trials. 12: 85. doi:10.1186/1745-6215-12-85. PMC 3074516. PMID 21426576. <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074516" target="_blank">https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3074516</a> <a href="#fnref:3" class="footnote-back-ref">↩</a></p></li>
</ol>

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Computerized Systems Used In Clinical Trials