【摘要】 规范生物等效性试验中受试者管理,提高临床试验质量。方法:以青岛大学附属医院Ⅰ期临床研究中心开展生物等效性试验的工作模式为依据,总结试验过程中筛选期、试验期、随访期等各个流程的受试者管理体会,探讨有效的管理措施。结果:通过第三方招募、专人负责对接,完全告知、充分知情,严格执行入排标准,选择合适的受试者,并全程监护、规范化统一管理,定期随访,互相尊重,可保障受试者安全,提高受试者依从性。结论:通过在筛选期、试验期、随访期等各个环节采取规范化管理措施,可提高临床试验的质量。更多还原

【Abstract】 OBJECTIVE To standardize the subjects management in bioequivalence trials and improve the quality of clinical trials. METHODS Based on the working mode of bioequivalence trials carried out in our hospital, the experience of subject management in screening period, trial period and follow-up period was summarized to explore effective management measures. RESULTS Recruiting by the third party, strictly implementing the entry and discharge standards, selecting suitable subjects, monitoring the whole process, and regular follow-up can ensure the safety of the subjects and improve the compliance of the subjects. CONCLUSION The quality of clinical trials can be improved by adopting standardized management measures in screening period, trial period and follow-up period and other procedures.更多还原