Abstract：The PDCA (Plan-Do-Check-Action) cycle was utilized in the hospital to carry out special
rectification of ICF (Informed Consent Form) in medical instrument clinical trials. Altogether 10 medical
instrument clinical trials and 312 ICFs that had been accomplished in Department of Orthopedics in the
hospital between January 2011 to December 2012 were selected as Control Group; while, 9 medical
instrument clinical trials and 298 ICFs that had been accomplished in Department of Orthopedics in
the hospital between January 2013 to December 2014 were selected as Rectification Group. In line
with quality evaluation criteria of ICF design and informed consent implementation, the scores of preand
post-rectification ICF design, informed consent implementation and each element were compared
and analyzed. The study result showed feasibility and effectiveness of application of PDCA in special
rectification of ICF in medical instrument clinical trials. It could significantly improve informed consent
quality of medical instrument clinical trials.
王磊，曲新涛，于秀淳. PDCA在我院骨病科医疗器械临床试验知情同意管理中的应用[J]. 中国医疗设备, 2016, 31(7): 146-148.
WANG Lei, QU Xin-tao,
YU Xiu-chun. Application of PDCA in Informed Consent Management in Medical
Instrument Clinical Trials in Department of Orthopedics in the Hospital. China Medical Devices, 2016, 31(7): 146-148.
