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Subjects

Subjects report elements return identifying information about the subject. This report element also includes a count item, which allows you to see totals for subjects, regardless of status.

Subjects report elements

Report element

Description

Subject Number

Data type: String

Description: The number that identifies the subject. This number can also be changed post-enrollment, if configured in the study.

Note: Subject number might not be unique at your site.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Subject Initials

Data type: String

Description: The initials of the subject enrolled in the study. These initials can be changed post-enrollment.

Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

Subject DOB (Screening)

Data type: Date

Description: The date of birth for the subject, as entered on the Screening form for the subject. The DOB field may or may not be used on the Screening form for your study.

You cannot change this date after the subject is enrolled. You can change it after the Screening form is submitted, as long as the subject has not yet been enrolled.

Many study designers also include a date of birth field for the subject on other clinical forms in the study to correct data entry errors that might have occurred when the subject was screened. Unlike the DOB field on the screening form, a DOB field on a clinical form can be changed at any time.

As a result, a subject may have two different dates of birth recorded in the Reporting and Analysis database; one recorded on the Screening form, and one recorded on another clinical form in the study. These dates may or may not match.

You can report on clinical DOB dates using report elements that appear in the Clinical Data by Form folder.

Data type: Clinical

SV Selected

Data type: Y/N

Description: Indicates whether the subject is selected for source verification.

  • Y—The subject is selected for source verification. All forms for this subject must be source verified.
  • N—The subject is not selected for source verification. Forms for this subject do not require source verification.

    Data source: Replicated from the InForm transactional database to the Reporting and Analysis database.

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