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Randomization Report Unblinded

This report displays the following unblinded information about randomization. Typically, unblinded statisticians use this report for the necessary data.

This table describes all possible fields for the report. Data in the report appears only in fields applicable to the study. Some fields might not appear in your report, and some fields could have different names.

Column

Description

Region

Area defined by the study team where the site is located (example: South America).

Country

Country where the site located (example: Brazil).

Investigator ID

Unique identification number for the investigator.

Site

Unique identification number for the site.

Name

Last name and first name of the Principal Investigator as entered at the site level.

Subject Number

Unique identification number for the subject.

Screening Number

Unique identification number assigned at screening. Typically, this is the same as the Subject Number.

Randomized

Date the subject was randomized.

Rand Number

Number assigned by the randomization schedule.

Treatment

Description of the treatment arm assigned during randomization.

Drug(s)

Number indicating the type of unit dispensed with the unit label in parenthesis (example: 1234 (A), 3456 (A)).

Forced

Whether randomization numbers were forced and assigned differently than the initial study design intended, based on which drug was available at the time of randomization.

Flag

Flags set for the subject (example: Mis-Randomized, or Off-Treatment).

Flag Comments

Comments entered when you flag a subject.

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