Changes after Data Entry

Overview

StudyTRAX was developed with flexibility in mind as we know that things change.   Most attributes in StudyTRAX can be changed even after the data entry has begun.  However, there are some attributes that cannot be changed to prevent corrupt data from existing in the database. 

Attributes that cannot be changed once data has been entered

Variable Groups/Variables:

• Variable type (although you can change between Pick List and Radio Button variable types)

• Decrease the length of a text variable
• Tighten the range of the min/max of a numeric variable (can't increase the min or decrease the max)
• Delete a pick list option
• Change the value of a pick list option
• Delete a variable  (but it can be made inactive)
• Cannot delete a variable group (but it can be made inactive)

Intervals:

• Delete an interval with encounters entered (but it can be made inactive)
• Change a fixed interval to a non-fixed interval or vice-versa
• Remove a variable group once data is collected on at least one variable that is part of the variable group (but the variable group can be hidden in that interval or made inactive for all intervals)
• Cannot change a Baseline interval to a non-baseline interval once data is entered for baseline

Project Configuration:

• Add/remove the following features from a project
  • Randomization
  • Screening
• Change the time point at which subjects are randomized
• Remove sites in which subjects are enrolled
• Reduce the maximum enrollment below the number of subjects currently enrolled
• Change Sequence by Site for the Project ID Generation once subjects have a generated Project ID 

Medications:

• Delete a medication from the central list once data is entered for the medication

Attributes that can be changed after data entry

Variable Groups/Variables:

• The following variable attributes:
  • Variable name
  • Variable description
  • Data Entry Prompt
  • Answer Suffix

  • Variable Code

    StudyTRAX will automatically change all references to the variable code

  • Variable type between radio button and pick list
  • Increase the length of a text variable
  • Increase the range of the min/max of a numeric variable (can decrease the min and increase the max)
  • The number of lines of text and memo variables
  • Add/modify/remove the default value

  • The required attribute of a variable

    This change may affect subjects' completion status

  • Active/Inactive
  • Exportable/non-exportable
  • Pick list option names
  • Add pick list options
  • Add missing values
  • Variable's layout
• Add variables
• Add/change the dependency
• Modify the variable group's layout
• Change the variables' and variable groups' display order
• Change the variable group name
• Change whether the variable group is active
• Change if other project can copy the variable group
• Change any of the layout definitions (e.g., page break, variable numbers)

• Add/modify a numeric calculation variable

  The value of a numeric calculation is determined at the time of export

• Assign and unassign universal subject variables (as long as the variable is not used in a calculation or dependency)

Intervals:

• Add intervals
• Modify interval name
• Modify interval target length and range
• Add variable groups to an interval
• Add/remove which variable groups are entered by the subject

• Add/modify interval expression

  This change may affect subjects' completion status

Project Configuration:

• Add/remove project features, except screening and randomization
• Add/modify/delete subject reports
• Add/modify/delete data sets, filters, workbench reports
•  Add/remove which identifying information is used and exportable

Medications:

• Add/modify medications
• Delete medications that have not been used