Enrolled Subjects

The Enrolled Subjects page displays the list of enrolled subjects for the current site. Screen Failures are not included in this list. Subjects can be added manually or through a Data Import from another system.

 

The user can add an item by selecting Active under the Records filter and clicking he Add New button or edit an item by clicking , which opens the Subject module. To find an item, enter a word or string in the Search filter and press enter. To remove all search options, click the Reset Filters button.

 

Most columns can be sorted in ascending or descending order by clicking the column heading.

 

Click Common Buttons for a description of the buttons found throughout the system and their uses.

 

 

 

Field

Description

Search Fields

 

Enroll Status

Records can be filtered by the Enrollment Status of each record. The available choices are:

  • Completed

  • Discontinued

  • Enrolled

Randomization Status

Records can be filtered by the Randomization Status of each record. The available choices are:

  • Randomized

  • Not Randomized

Gender

Records can be filtered by the gender of each record. This filter will be hidden if the Enable Subject Gender configuration variable under the Enrollment configuration group is set to False. If visible, the available choices are:

  • Female

  • Male

  • Unknown - This choice will be hidden if the Enable Subject Gender Unknown configuration variable under the Enrollment configuration group is set to False.

Protocol Version

Records can be filtered based on the Protocol Version of each record. The available choices are the list of active Protocol Version records for the current Project.

Subject Group

Records can be filtered based on the Subject Group of each record. The available choices are the list of active Subject Group records for the current Project.

Records

The user can filter the institutions based on whether the records are active or inactive, or simply select all records.

Search

The user can enter any word or string to see if it exists in the institutions database.

ENROLLED

 

Subject

This column lists the subject identification number.

Status

This column lists where the subject is in the study. The choices include:

    • Blank box = Enrolled

    • Check = Completed

    • Red X = Discontinued

Enroll Date

This column lists the subject's enrollment date.

RANDOMIZATION

This section will be visible when the Enable Subject Randomization Configuration Variable under the Enrollment configuration group is set to True, or when the Project is not licensed for IWRS.

Randomization Icon

This column lists where the subject is in the study. The choices include:

    • Blank box = Not Randomized

    • Check = Randomized

Number

This column displays the Randomization Number assigned to the subject. This number is assigned on the Enrollment tab of the Subject module.

Randomization Date

This column displays the date when the subject was assigned their randomization number. This number is assigned on the Enrollment tab of the Subject module.

PROTOCOL

 

Protocol Version

This column indicates the protocol version that was used when the subject was enrolled.

Subject Group

This column will be hidden if Subject Groups have not been defined for the current project.

Comment

This column lists any comments or notes made for this subject.