Target Health Resources

Lessons Learned From Direct Data Entry

In order to assess the impact of direct data entry (DDE) on the clinical trial process, a single-site, phase 2 clinical trial, under a US investigational new drug application (IND), was performed where the clinical site entered each subject’s data into an electronic data capture (EDC) system at the time of the office visit and the clinical research team implemented a risk-based monitoring (RBM) plan.

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Drug Information Journal
Jules T. Mitchel, MBA, PhD, Judith M. Schloss Markowitz, MS, Hua (Helen) Yin, MS, Dean Gittleman, MS, Timothy Cho, BS, Yong Joong Kim, MS, Joonhyuk Choi, BS, Efros, MD, FACS2 , Kerri Weingard, ANP, MS, BSN, RN, Vadim Tantsyura, MS, MA, and Dario Carrara, PhD
July 4, 2012

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