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Subject Procedure Group Randomization Subject allocation to procedure group (A or B) will be via a randomized block design with varying block sizes of two, four and six subjects. In each block, one-half of the subjects will be randomly assigned to Procedure Group A and the other half will be randomly assigned to Procedure Group B. In addition, randomization will be stratified by (i) category of baseline Summary Index score on the PDQ-39 (PDQ-39SI) (low or high) and by (ii) test site. A ‘low’ PDQ-39SI is one that falls between 15 and 29.99; a ‘high’ PDQ-39SI is one that is 30 or greater. Randomization will be attained using computer generation sequence methodology, insuring that the randomization methodology and the generated allocation sequence is concealed from the investigator and subjects. Concealment will be insured as follows:
Each individual subject randomization (A or B) will be placed in a separate sealed envelope by the study Monitor. For example, the first few envelopes would be labeled:
These envelopes will be maintained at the test site’s clinical site where the procedure administrations with the Resonator™ device are performed. Once a subject has qualified for and enrolled in the study at the test site’s testing site, the Principal Investigator will contact the associated clinical site to notify them that a subject has qualified and a first procedure administration visit needs to be scheduled for that subject at the clinical site. This subject’s subject ID will be recorded on a master sheet at the clinical site according to their order of enrollment in the study for that test site and his or her PDQ-39SI category. For example, subject AB004 at test site #1 whose baseline PDQ-39SI is 25 would be recorded in the spot for the ‘fourth subject at test site #1 with a low baseline PDQ-39SI.’ When that subject attends the clinical site for his or her first procedure administration visit, the procedure administrator will select the appropriate corresponding envelope, open it, and record the procedure group label (A or B) contained inside on the subject’s group assignment case report form that along with the procedure administration record form will be maintained only in the subject’s file at the clinical site. The procedure administrator is the only individual in the study who will have access to a subject’s group assignment (A or B), although he or she will not be informed of which procedure (A or B) is the actual (device active) procedure. Neither the subject nor the assessment investigators will have access to or be informed of any subject’s A or B group assignment. |
4700 140th Ave. N., Suite 101 • Clearwater, FL 33762 • 727-474-3722 |
