Common use of Treatment Assignment / Randomization Clause in Contracts

Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 manner to receive either the contact lenses, respectively. or Biofinity Only after signing the ICF, a subject will be assigned a subject number by the electronic data capture system. A randomization list will be generated using a validated system that automates the random assignment of treatment arms to randomization numbers in the specified ratio Subjects will be assigned a treatment arm according to the randomization list uploaded in the IRT system. The randomization list will be generated and maintained by the Study Sponsor. At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one of the treatment arms. The Investigator’s delegate will access the respective system after confirming that the subject meets all the eligibility criteria. A randomization number will be automatically assigned to the subject according to the subject randomization list but will not be communicated to the site user. The EDC/IRT integration system will inform the site user of the treatment assignment to be dispensed to the subject.

Treatment Assignment / Randomization. Subjects will be randomized in a 1:1 2:1 manner to receive either the contact lenses, respectively. or Biofinity Only after signing the ICF, a subject will be assigned a subject number by the electronic data capture system. A randomization list will be generated using a validated system that automates the random assignment of treatment arms to randomization numbers in the specified ratio Subjects will be assigned a treatment arm according to the randomization list uploaded in the IRT system. The randomization list will be generated and maintained by the Study Sponsor. At Visit 1, all eligible subjects will be randomized via the EDC/IRT integration system to one of the treatment arms. The Investigator’s delegate will access the respective system after confirming that the subject meets all the eligibility criteria. A randomization number will be automatically assigned to the subject according to the subject randomization list but will not be communicated to the site user. The EDC/IRT integration system will inform the site user of the treatment assignment to be dispensed to the subject.