Study Treatment Assignment Sample Clauses

Study Treatment Assignment. All study medication will be supplied by Glaxo Wellcome and shipped to the study sites by either Glaxo Wellcome or Almedica. After all appropriate regulatory and ethical approval documents have been received and approved by Glaxo Wellcome, study medication will be sent to the site. Subjects will be assigned to study treatment in accordance with the randomisation schedule, which will be generated using the GW computer program Patient Allocation for Clinical Trials (PACT). Medication will be allocated by the use of three numbers as follows; • Each subject who is screened will be allocated a subject number. This number is unique to each subject and will be assigned from a list provided to the site, in chronological order. • Each subject who satisfies the randomisation criteria will be assigned a unique treatment number from the Interactive Voice Response (IVR) system which is part of the System for Central Allocation of Drug (SCAD). Once a treatment number has been assigned to a subject, it cannot be assigned to any other subject. Neither the subject nor the investigator will know to which treatment arm a subject has been allocated. • At each treatment visit the subject will be provided with a treatment pack. Every pack number is unique and corresponds to the study medication pack to be dispensed to the subject at this visit A specialist IVR system company, ClinPhone, will manage this system. At the randomisation visit (Visit 2) the principal investigator or designee will contact the IVR system through an automated 24-hour telephone number; upon providing their unique personal identification number (PIN) and answering a series of questions, the site will be provided with the subject’s treatment number as well as a pack number. Study treatment packs are to be allocated in this way to avoid storage and over-supply issues that would be caused by supplying numbered patient packs. At the randomisation visit (Visit 2) smoking status at visit one is recorded in the IVR system. Smoking status will be a stratifying variable with regard to treatment allocation. 3.3.2.1. Procedures for breaking the randomisation code Only in the case of an emergency, when knowledge of the study drug is essential for the clinical management or welfare of the subject, the investigator may unblind a subject’s treatment assignment. The principal investigator at each site will be provided with an automated 24-hour contact telephone number in order to break the code should a medical emergency...
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