医院Ⅰ期药物临床试验病房实行临床试验过程管理分析

Clinical trial process management analysis of clinical trial wards with drug phraseⅠof the hospital

Ⅰ期临床试验属于开展新药人体试验的重要时间段,其目的在于进行初步临床药理学以及人体用药安全性评价。Ⅰ期临床试验病房属于开展新药Ⅰ期临床试验的重要基地和场所,在临床试验过程中要严格落实药物临床试验质量管理规范(GCP)相关要求和规定。因而,临床试验过程管理具有重要价值。一方面,要强化病房管理,含抢救室管理、采血室管理、病房管理、药品室管理、样本室管理等;二方面,要强化软硬件管理;三方面,要强化受试者管理,含受试者的招募管理、把关筛选、宣教、不良事件的追踪和处理、受试者的饮食管理和心理护理等;四方面,要强化研究护士管理及培训。

Clinical trial phase Ⅰ is an important phase for human trials of new drugs,and its purpose is to conduct a preliminary clinical pharmacology and human body safety evaluation.As clinical trial wards of phaseⅠare the important bases and places for clinical trials phase Ⅰ of new drugs,the related requirements and regulations of good clinical practice(GCP)should be strictly implemented.Therefore,the management of the clinical trial process is of great value.Firstly,the management of wards,emergency room,blood collection room,medicine room and sample room must be reinforced;secondly,the management of hardwares and softwares must be enhanced;thirdly,the management of the trial subjects must be strengthened,including the tracking and handling of adverse events as well as the subjects’recruitment,screening,education,diets and mental nursing;and lastly,the management and training of the nurses must be intensified.