| 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 confim 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. <IMAGE> |
