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1. 发明授权

US5898586A Method for administering clinical trail material 失效
标题翻译：管理临床踪迹材料的方法
公开(公告)号：US5898586A
公开(公告)日：1999-04-27
申请号：US334411
申请日：1994-11-04
申请人： Thomas L. Jeatran , Roy N. Tamura , James Monroe Solenberg, Jr.
发明人： Thomas L. Jeatran , Roy N. Tamura , James Monroe Solenberg, Jr.
IPC分类号： A61J1/14 , A61B5/00 , A61K49/00 , G06F19/00 , G06Q50/22 , G06F153/00
CPC分类号： G06F19/363 , G06Q50/22 , G06F19/3462
摘要： A method for administering clinical trial material includes a method for administering clinical trial material, comprising the steps of providing at least one kit containing a plurality of bottles, each with two separate indicia appearing thereon, at least one of the bottles containing a quantity of clinical material at a first dosage, and another at least one of the bottles containing one of a quantity of the clinical material at a second dosage, a quantity of control drug and a placebo; identifying first and second study groups, each providing a treatment schedule for administering dosages of at least one of the clinical material, the control drug and the placebo, the first and second study groups having different treatment schedules; randomly assigning patients to the first and second study groups; assigning at least one investigator to administer the contents of the plurality of bottles; telephone means accessible to the investigator and having a keypad; providing sponsor computer means including telephony capabilities and for storing information, disseminating information, and instructions over the telephone to the investigators, and for receiving information and instructions over the telephone from the investigators, the computer means operable, upon being contacted by the investigator, to identify which of the plurality of bottle of the kit is to be disseminated to an identified patient, but requiring the investigator to confirm selection of the correct bottle by requesting the investigator to enter into the telephone keypad one of the identifying indicia appearing on the selected bottle; and distributing the at least one kit to said investigator.
摘要翻译：一种用于施用临床试验材料的方法包括一种用于施用临床试验材料的方法，包括以下步骤：提供至少一个试剂盒，该试剂盒含有多个瓶子，每个试剂瓶上出现两个分开的标记，至少一个瓶子含有临床试验材料第一剂量的材料，以及另一个至少一个瓶子，其含有一批第二剂量的临床物质，一定量的对照药物和安慰剂; 识别第一和第二研究组，每个研究组提供治疗计划，用于施用至少一种临床材料，对照药物和安慰剂的剂量，具有不同治疗方案的第一和第二研究组; 随机分配患者到第一和第二研究组; 分配至少一个调查员来管理所述多个瓶子的内容物; 调查员可访问电话，并具有键盘; 提供包括电话能力的赞助计算机装置，以及通过电话将信息，传播信息和指令传送给调查员，以及通过电话从调查员接收信息和指令，该计算机装置可在调查员联系之后操作，识别该组件的多个瓶子中的哪一个要传播给识别的患者，但是要求调查员通过请求调查员进入电话键盘来确认选择正确的瓶子，其中出现在所选择的瓶子上的识别标记之一 ; 以及将所述至少一个试剂盒分发给所述研究者。

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