三甲医院临床研究项目执行质量评估体系的探索

Exploration of the clinical research implementation quality assessment system in top three hospitals

目的为了建立三甲医院临床研究项目的执行质量量化评估体系。方法通过文献分析、头脑风暴和德尔菲专家咨询法，建立评估指标及相应的指标权重，并利用实际课题验证评价过程和方法。结果建立五个一级指标和十个二级指标的评估体系，从项目进度、伦理审查、知情同意、研究病例、经费使用五个方面建立执行评估体系。结论该评估体系能够有效评估临床研究，适合』临床研究执行过程质量管理。

Objective To set up the measurable Clinical Research Implementation Quality Assessment System in Top Three Hospitals. Methods The literature analysis, brain storm and Delphin Method were adopted to establish the evaluation indicators and related index weight, the assessment procedures and method were used in real clinic research for verification. Results An Assessment Sys tern, which was made up by five primary indexes, including research progress, ethical review, informed consent, case study and budget, as well as ten secondary indexes were established. Conclusions The Assessment System plays an important role in the evaluation of clinical research and appropriate for the process management of research implementation.