RESUMO
Objective To construct the evaluation indicator system for clinical scientific research on data quality; To provide a basis for assessing data quality of clinic scientific research.Methods Evaluation indicator system for clinic scientific research on data quality was established based on literature review and expert suggestion. A two- rounds Delphi process was conducted and the specialist participating level, concentration degree, coordination degree and authority coefficient were calculated to assess the indicator system.Results Two rounds of Delphi consultations was conducted by 30 experts that from different majors at the department of internal medicine or surgery, and both the effective recovery rates were 100%; the average authority coefficients of expert were 0.79 and 0.81, respectively. In the second round of survey, the final concentration degree ranged from 46.67% to 54.69% at full mark rate, and 4.23 to 4.36 at the mean values in 5 primary indicators. The CV for average 5 primary indicators ranged from 0.11 to 0.18. After 2 rounds of expert consultation, the final indicator system was consisted of 5 primary indicators (CRF construction, random control process, informed consent, data capture and data validation), 18 secondary indicators and 63 third-class indicators.Conclusion After two rounds of consultation, the opinions of all experts have been tending to be uniform, with high degree of coordination, and the indicator system can be used in assessment of data quality of clinic scientific research.