Viewing the subject details
This screen enables you to create labels and expressions that are evaluated for individual subjects during data entry.
Select View > Study Details or click the Study shortcut button located on the toolbar beneath the menus.
Click the Subject Details tab to display the Subject Details window.
The subject label is used to identify subjects in a study, and is defined as an Arezzo expression which will be evaluated for each subject in the study during data entry. You do not have to define a subject label. If no subject label is defined, subjects will be automatically assigned a numerical identifier.
The subject label should consist of information that is unique to an individual subject, for instance a combination of initials, date of birth and site. However, checks are not made to ensure that subject labels are unique. If a subject label has been specified in a study, it will always be displayed in the Data Entry/Review modules as soon as the relevant information is available. It will be displayed above the schedule and in the lists of existing subjects.
If the information referenced in a subject label or the expression itself is changed or deleted, the subject label will be automatically updated.
To create a subject label, enter an Arezzo expression into the text field, either by typing directly into the field, or by clicking the fx button and using the expression builder. See image
The value returned by the expression will be used as the subject label.
We recommend that your subject label is based on questions that appear near the beginning of the study, as the label will remain incomplete until the relevant questions have been answered. It is possible for only a part of the label to be displayed.
The maximum number of characters allowed for a subject label is 4000.
screening:cover:initials & ' ' & screening:cover:subject would return the values of the 'initials' and 'subject' questions from the 'cover' form. This label may look something like JKD 115.
It is only necessary to enter this expression if there are laboratory test questions in the study that may have age-specific normal ranges. The Arezzo expression must evaluate to a value of type date/time, representing the subject's date of birth, for example
screening:cover:dobirth
From this the subject's age will be calculated and used for normal range validation.
If the information referenced in the subject DOB or the expression itelf is changed or deleted, the derived subject DOB will be automatically updated.
Note: The questions from which a subject's date of birth is derived must be on an eForm which occurs before any lab test questions are answered.
It is only necessary to enter this expression if there are laboratory test questions in the study that may have gender-specific normal ranges. The Arezzo expression must evaluate to 1 for female and 2 for male. We recommend that you create a gender question as a category question with these codes and values. The gender will then be, for example,
screening:demography:sex
If the information referenced in the subject gender or the expression itelf is changed or deleted, the derived subject gender will be automatically updated.
Note: The questions from which a subject's gender is derived must be on an eForm which occurs before any lab test questions are answered.
These details are all listed in the Annotated CRF report.
Related Topics
Setting up subject registration