Discussion of risks of application of mobile medical applications in data capture during drug clinical trials
WEN Ke
WANG Jin
CAI Yun
BAI Nan
WANG Rui
Abstract：The authenticity and completeness of drug clinical trial data are the basis for correct evaluation of the effectiveness and safety of investigational products.There have no relevant provisions in China yet on whether mobile medical applications can be applied in data collection of drug clinical trials.It was learned through identification and assessment of the risks of mobile medical applications that there is potential high risk in terms of subjects' information security,effectiveness and safety and the quality of data capture.Therefore,relevant policies or technical guidelines are needed to solve the problems faced by mobile medical applications during data capture,including the definition of compliance,risk-based hierarchical supervision and the scope of data collection.Ethical committees and research institutions also need to evaluate whether the risks will be higher than the minimum risk when mobile medical applications are being applied before the trial is conducted.
Keywords：clinical trialsrisk managementmobile medical applicationdata capture
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2706-2709 )