Feature Selection

Table of Contents

Overview

Click here for an overview of features available in StudyTRAX.

What to Consider

Adverse Events

• All of a subject's adverse events are displayed on the Adverse Events tab of the Subject Overview page
• Adverse Events that are not resolved are highlighted red
• A PDF report of all adverse events for the project can be viewed/printed for a desired date range
• Limitations
  • The variables cannot be modified
  • The report cannot be modified
• An alternate option to using the StudyTRAX Adverse Events feature is to create a variable group with your custom variables and attach the variable group to a non-fixed interval

Change Reason

• When a subject's data is modified the user will be prompted to enter a reason for the data change
• All data changes are tracked in an audit log even if Change Reason is not enabled

Double Data Entry

• A Double Data Entry Delta Report displays error rates and discrepancies between primary and secondary entries
• Only primary entry values are exportable through data sets
• The variables to be double data entered are selected
• The subject's which will be double data entered are selected

Medications

• A Medications tab is displayed on the Subject Overview page where all of a subject's medications are visible
• Medications are selected from a list so they do not have to be typed
• Medications that are available for selection must be added or imported into the central list
• Medications in the central list must include:
  • Trade Name
  • Generic Name
  • Code (a unique identifier for the medication)
  • Unit of Measure
• When Medications are entered for a subject they include:
  • Medication Name - selected from the list
  • Begin Date - must be entered in full date format - mm/dd/yyyy
  • End Date - optional but if entered must be in full date format - mm/dd/yyyy
  • Dose - must be entered in the unit of measure specified for the medication in the central list
  • # / Day - must be entered as a whole number although 0 can be used
  • Notes - an optional field
• Data Sets
  • Medication Groups can be created to define dose equivalenc scales for related medications
  • Medication Groups can be exported in one column of a data set
  • Medication Group Dosage and Medication Grouop Exposure (has ever taken) can be exported for a medication group
  • Medication Dosage and Medication Exposure (has ever taken) can be exported for medications that are assigned to the project
    • Has Ever Taken:  Outputs a 0 (No) or 1 (Yes) if the subject has ever taken the medication
    • Dosage:  Outputs the dosage at an encounter based on the begin/end date of the medication and the date of the encounter
• Limitations
  • The subject medication fields cannot be modified
  • Only medications assigned to a project can be exported through data sets

    Medication Groups can be created from any medications in the central list and then exported

• Alternate options
  •  Create a Project Variable Group that is a log of all subject medications
    • The variables can be customized
    • All of a subject's medications will be visible on one form
    • When exporting the data each medication will be in a separate column
  • Create an Encounter Variable Group and assign to a non-fixed encounter
    • The variables can be customized
    • Each medication will be a separate non-fixed interval
    • A subject report can list all of a subject's medications on one report
    • When exporting the data each medication will be in a column
    • When it is expected that subjects will have numerous medications this option will result in many non-fixed intervals
      

Randomization

• View information about the randomization configuration (randomization methods, blinding, stratification):  Randomization
  • What randomization method will be used?
  • Who can randomize a subject (there is a separate randomization role)?
  • Who can access / un-blind randomization (there is a separate view randomization assignment role)?
• What are the practical mechanics involved in randomizing a subject?
• How will subjects be screened (e.g. inclusion/exclusion criteria, run-in period design)?
• Be sure there will be enough subjects to reasonably ensure the distribution across strata blocks are filled when using Stratification Factors
  • In pilot studies the limited sample size typically limits the number of strata that can feasibly be used, maybe 1 or 2 variables at most. 

    The number of strata are multiplicative across variables (e.g., 2 variables with 2 categories each = 4 strata groups)

• Review if there are known confounding factors that need to be controlled
  • The variables should be controlled in the randomization scheme (e.g., smoking status for a study on lung cancer)
  •  Consider the main dependent measure and whether any of the proposed stratification varaibles are 1) markedly related or 2) would differentially interact with the intervention

Screening

• Screening is used to determine if a subject meets the criteria to be included in the study
• There can be multiple screening encounters
• Screening encounters can also be used for visits that occur before Baseline/Time 0 but do not affect screening status
  • The encounter that is set for Baseline determines the projected date of the follow-up encounters
  • Baseline would be set for the visit that starts the timeline and prior visits would be set up as screening visits
• All screening encounters must occur before Baseline/Time 0
• Subjects who have not passed screening (they are still in-process or failed screening) cannot move to their Baseline or Follow-up encounters

Subject Login

• Used to allow subjects to log in and enter data
• Subjects are set up with their own username and password from the Subject Overview page (by users with a Subject Administration role)
• Subjects will only see the forms that are selected
• See the Subject Data Entry page for more details 

Versioning

• This is not a common feature and complicates the project setup, verify this feature is desired before enabling
• Versioning must be enabled to use Electronic Signatures
• Unless you are testing the feature, do not turn it on until all the variable groups are created
• With versioning enabled every change to a variable group requires a new version
• Subjects that had data entered using a previous version can be upgraded to the new version of the variable group
• Limitations
  • You cannot select which version a subject will be upgraded to, they can only be upgraded to the latest version
  • Correcting errors when there are a lot of subjects and/or encounters would require upgrading for each subject's encounter
    

Electronic Signatures

• Allows a variable group to be electronically signed which locks the values and prevents changes
• Versioning is required to enable Electronic Signatures
• Separate roles are available for users to sign and/or un-sign a variable group
• Variable groups are selected as to whether they can be electronically signed
• Each variable group that is being signed or un-signed is checked and a password entered
  

Examples