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The randomization visit
Randomization assigns a subject to a treatment group. This step cannot occur until the subject has been registered in IRT during the screening visit.
During randomization, IRT does the following:
- Assigns a randomization number to the subject.
- Assigns a subject number to the subject.
- Identifies the exact drug units to provide to the subject.
- Adds the subject to the total count of randomized subjects for the study that is maintained in IRT.
In the randomization visit, you do the following:
- Verify the subjects' identity against the basic demographic information gathered during screening.
- Randomize the subject.
- Provide other information required by the protocol.
- Provide the exact drug unit identified by IRT to the subject.
- Confirm the information you have logged is correct.
When you complete the visit, IRT sends you an email confirmation as a record of the information you entered.
Some protocols require additional randomization visits. These secondary randomization visits are included in the appropriate order in the visit schedule.
