Page Comparison

Adverse Events

Allows collection of subject's adverse events.

Change Reason

Prompts the user for a reason for all subject data changes.

Double Data Entry

Allows a selected list of encounter variables to be double entered.  A Double Data Entry Summary report displays the differences between the original values and the secondary values.

Electronic Signatures

Allows a selected list of variable groups to be electronically signed, locking the values.  Versioning is required to enable Electronic Signatures.

Medications

Allows subject medications to be collected.

Randomization **

Allows subjects to be randomly assigned to treatment groups.  If screening is enabled, stratification variables can be selected.

Screening **

Allows implementation of intervals prior to baseline that determine if a subject meets the inclusion/exclusion criteria.

Subject Login

Allows subjects to log into StudyTRAX and enter their own data.

  Allow View History

Allows subjects to see data they entered for prior visits/encounters.

  Allow Edit Past Forms

Allows subjects to edit the data they entered for prior visits/encounters.

  Allow Disable Notifications

Allows subjects to turn off the email notification when an encounter is due.

  Project Name For Subjects

The name entered in this field will display as the project name for subjects.  If no name is entered, subjects will see the project name as set up in StudyTRAX.

Versioning

Allows variable groups to have one or more versions.  Modifications to a variable group require a new version.  Subjects that had data entered using a previous version may be upgraded to the new version of the variable group.