CAJ | 학술논문

目的：探讨临床研究不良事件的报告标准与数据质量要求。方法分析3种情况下不良事件的报告标准，举例说明 MedDRA 编码对不良事件报告原始数据的质量要求。结果①研究疾病的加重：研究疾病预期的自然进展不视为不良事件，除非其疾病的变化形成了新的医学诊断。②异常的实验室检查结果：异常实验室检查值只有在其伴随临床症状或体征，或需要接受医疗干预，或研究者评价具有临床意义时，才被视为不良事件。③反复出现的不良事件：转归为痊愈或消失的不良事件再次出现时，需要再报告一条 AE。④用 MedDRA 字典进行编码，要求原始数据应是清晰、简洁、完整和准确的。结论在制定方案时，应对不良事件的报告标准给出尽量具体的规定，试验启动前做好相关培训，以统一报告标准，提高原始数据质量。
목적：탐토림상연구불량사건적보고표준여수거질량요구。방법분석3충정황하불량사건적보고표준，거례설명 MedDRA 편마대불량사건보고원시수거적질량요구。결과①연구질병적가중：연구질병예기적자연진전불시위불량사건，제비기질병적변화형성료신적의학진단。②이상적실험실검사결과：이상실험실검사치지유재기반수림상증상혹체정，혹수요접수의료간예，혹연구자평개구유림상의의시，재피시위불량사건。③반복출현적불량사건：전귀위전유혹소실적불량사건재차출현시，수요재보고일조 AE。④용 MedDRA 자전진행편마，요구원시수거응시청석、간길、완정화준학적。결론재제정방안시，응대불량사건적보고표준급출진량구체적규정，시험계동전주호상관배훈，이통일보고표준，제고원시수거질량。
Objective To discuss the reporting standards and quality of adverse events (AEs) in clinical researches. Methods The reporting standards of AEs on three occasions were analyzed and the quality requirements of the original data when coding with MedDRA terminology were illustrated. Results ① Aggravation of researched diseases: the natural course of diseases is not considered as AEs unless it develops into a new diagnosis. ②Abnormal results of laboratory examinations: there are three occasions in which abnormal results are regarded as AEs, along with clinical symptoms or signs, the need of implementing medical intervention, clinically significant. ③Repeating AEs: it is neces-sary to report another AE once a disappeared or recovered AE happens again. ④The original data should be clear, concise, complete and accurate if AE terms are coded with MedDRA terminology. Conclusion The standards of AE reporting should be specified in study protocols and conduct trainings before starting a trial in order to unify the reporting standards and improve the quality of original data.