Summary

This article is a guide to help the Software Implementation Specialist (SIS) determine the correct utility to use to implement various study modifications. 

Table of Contents

• Utilities Initiated in Subject Manager
  • Initiate the Action
  • Insert Form
  • Move Form
  • Move Record
  • Reconcile Form
  • Refresh Metadata
  • Rename Form
  • Update Form Config
  • Update Question Type
• Utilities Initiated in Actions Tab
  • Reconcile
  • Reconcile Record
  • Reconcile Code Status
  • Update Name
  • Update Questions
    • Example
  • Update Question Display Utility
• Utilities Initiated in Form Summary and Form Manager
  • Update Sequence
• When to Run Utilities

Study Modifications, also known as Mid-Study Changes, often involve the removal or addition of portions of the casebook which do not immediately affect existing subjects. These can be new forms, new edit checks, removing edit checks, or any other variation that would occur after the initial study deployment.
The goal of this guide is to help the designer determine the correct utility to use to implement these various changes.

Utilities Initiated in Subject Manager

The following are utilities that can be initiated in Subject Manager and are used to address study modifications.

Note: Make sure screen and action permissions have been assigned to the proper roles before following this tutorial.

Initiate the Action

Follow these steps before continuing on to the directions specific to each utility.

1. Access the Subject Manager by clicking the Subjects tab within the trial.
2. Check the box next to each subject that you wish to run the utility for.
3. In the ‘Choose an Action’ dropdown menu select the utility you wish to use on the selected subjects from step 2.
4. Click the ‘Go’ button.

Insert Form

Insert Form inserts a form into an existing subject. The process can be used on multiple subjects through the Subject Summary. The inserted form can be either a static or a dynamic form.

Note: The process should only take a few seconds to run but could take up to a few minutes if running for several patients.

1. Apply To: Select the subject to which the insertion should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Add: Click the dropdown menu and select the Form ID you wish to insert.
3. To: Enter the absolute path of the location where you want the new form inserted.
   • Example: To insert a new form under the form called “screening,” enter the following: #screening
4. Sequence (Optional): This is the position number of where the form should be moved under the new path.
   • The sequence numbers start at 0. i.e. “2″ would make the form the third form under the path specified.
5. Form Name (Optional): This is the name of the inserted form. If no name is specified it will use the default name provided in the Form Name column on the Forms-Template tab in the Data Architect file.
6. Increment?: Check this box if the inserted form is a dynamic form.
7. Click the Save button.
   • When the Insert Form process is complete you will see a message that says “Added on X Record(s)” where X is the number of records that were selected to be updated.

Move Form

Move Form moves a form from one parent form to another. Move Form can be used on multiple subjects through the Subject Manager.

Note: The process should only take a few seconds to run but could take up to a few minutes if running for several patients.

1. Apply To: Select the subject to which the move should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Form: Enter the absolute path to the form that needs to be moved.
   • Example: To move a form from the form “enrollment demographics,” enter the following: #enrollment.demog
3. Move to: Enter the absolute path to the location where the form needs to be moved to.
   • Example: To move a form to the form called “baseline,” enter the following: #baseline
4. Sequence (Optional): This is the position number of where the form should be moved under the new path.
   • The sequence numbers start at 0. i.e. “2″ would make the form the third form under the path specified.

Note: If a sequence value is provided, verify the results and run Update Sequence if needed.

5. Click the Save button.
   When the Move Form process is complete you will see a message that says “Moved X Record(s)” where X is the number of records that were selected to be updated.

Move Record

Move Record moves a record (subject) from one tool (site) to another within the site network. Move Record can be used on multiple subjects through the Subject Manager.

1. Click the radio button next to the tool that you wish to move the subject to and click the OK button.

Reconcile Form

Reconcile Form loops through the specified records and re-evaluates the dependencies for the specified form. Scripts and assignments can also be re-evaluated if the appropriate options are selected. Visit Manager settings (Actual Date, Expected Date, Begin Window, and End Window) can be re-evaluated to update the visit calculations and questions with newly assigned medical coding dictionaries.

Note: The process should only take a few seconds to run but could take up to a few minutes if running for several patients.

Keep the following in mind when running this utility:

• Without other options selected, Reconcile Form re-evaluates the dependencies only. Scripts and assignments are not re-evaluated.
• Selecting the ‘Process Assignments’ option will re-evaluate all scripts and assignments on “touched” (i.e. previously answered) forms. All dependencies will also be re-evaluated.
• Selecting the ‘Process Assignments’ option and the ‘Update Assignments’ option will re-evaluate all scripts and assignments on both “touched” and “untouched” (i.e. not previously answered) forms. All dependencies will also be re-evaluated.

1. Apply To: Select the subject to which the reconcile should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Form: Fill out the complete form address. This is the absolute path to the form that needs to be reconciled.
   • Example: To reconcile a form called “demography,” enter the following: #enrollment.demog
3. Process Assignments?: Check the box if the user wants to re-evaluate assignments. It should be left blank if only reconciling dependencies.

It is best practice to not run Reconcile on a Form that contains an assignment to a form with the Increment Property. When using the Increment Property, if another form contains an assignment back to the form with the Increment command and reconcile is run on the form with the assignment the incremental numbering increases by one causing the loss of values in the sequence. It is best practice to not create an assignment on another form that writes back to the form with the incremental command.

4. Update assignment…: Check the checkbox to evaluate new assignments. It should be left blank if only reconciling dependencies.

Note: This option should only be selected under one of the following conditions:

• If you are reconciling a form with “untouched” questions
• The form has a blank answer status and you are 100% sure the reconciliation will result in value changes

5. Click the Saved button.
   Once the Reconcile Form process is complete you will see a message that says “Reconciled on X Record(s)” where X is the number of records that were reconciled.

Refresh Metadata

Refresh Metadata is typically used after a form has been moved and in some instance when a question is added to form. Refresh Metadata can be used on a single subject, multiple subjects, or all subjects in a tool. When a form has been moved, both the previous container and the new container of the form should have Refresh Metadata run for its address. Run the utility at the point the discrepancy occurs.

1. Apply To: Select the subject to which the refresh should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Form: Enter the absolute path to the form that needs to be updated.
   • Example: To refresh a form called “demography,” enter the following: #enrollment.demog
3. Press the Save button.
   • When the Refresh Metadata is complete you will see a message that says “Updated on X Record(s)” where X is the number of records that were updated.

Rename Form

Rename Form changes the name for the specified form by overriding the form name specified in the Data Architect. Rename Form can be used on a single subject, multiple subjects, or all subjects in the tool.

Note: The process should only take a few seconds to run but could take up to a few minutes if running for several patients.

1. Apply To: Select the subject to which the rename should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Form: Enter the absolute path to the form that will be renamed.
   • Example: To rename a form currently called “demography,” enter the following: #enrollment.demog
3. Form Name: Enter the desired name of the form selected.
4. Press the Save button.
   • When the Rename Form process is complete you will see a message that says “Renamed on X Record(s)” where X is the number of records that were updated.

Update Form Configuration

Update Form Configuration allows a form’s alias and/or type to be changed. This utility can be used on a single subject, multiple subjects, or all subjects in the tool.

Note: The process should only take a few seconds to run but could take up to a few minutes if running for several patients.

1. Apply To: Select the subject to which the configuration should be applied. The choices given will be:
   • These Records – to apply the utility to all subjects selected previously
   • This Record – to apply the utility to the single subject selected
   • All Records – to apply the utility to all subjects in the study
2. Form: Enter the absolute path to the form that needs to be updated. i.e. #baseline.demog
   • Example: To change a form alias from “demog” to “demography,” enter the the current path (for example): #enrollment.demog
3. Set alias to(Optional): Enter new form id/alias of the form being updated (in this case, for example, enter demography). If no alias is specified, the alias of the form will not change.
4. Set type to(Optional): Enter the form type of the form being updated. If no type is specified, the form type will not change.
5. Press the Save button.
   • When the Update Form Configuration process is complete you will see a message that says “Updated on X Record(s)” where X is the number of records that were updated.

Update Question Type

The Update Question Type changes a question’s question type, answer options, or date data type format (full to partial).
Reference page Update Question Types Utility to implement utility.

Utilities Initiated in Actions Tab

The following are utilities are also used to address study modifications, but are configured in a different way from the utilities in the previous section.

Note: Make sure screen and action permissions have been assigned to the proper roles before following this tutorial.

Reconcile

Reconcile loops through all records to re-evaluate dependencies and will trigger or clear them. It can be used to add new dependencies after a study has been deployed. It can also be used to add a medical dictionary to a question after a study has been deployed and the question did not contain an assigned medical dictionary. Reconcile runs across all sites and causes all tools in that network to be re-evaluated, rather than just records at the all sites level.

Note: The process can take anywhere from a few minutes to an hour or more depending on the size of the casebooks and the number of patients in a trial.

Reconcile actions do not evaluate dependencies on newly added questions to forms.

1. Hover the mouse over the Actions menu and select ‘Reconcile.’
   • The system will display a dropdown list of Reconcile actions.
2. From this list select
   • Reconcile to re-evaluate the dependencies only
   • Reconcile (Process Assignments) to re-evaluate all dependencies and scripts/assignments on “touched” forms.
3. Hover over the Reconcile action to see when the utility was ran last and its previous result.

Reconcile Record

Reconcile Record works the same way as Reconcile, but only re-evaluates the dependencies for a single record. It locates a record through Choose Record.

Note: Reconcile Record only re-evaluates the dependencies.

1. Hover the mouse over the green Actions menu and select ‘Reconcile.’ This should produce a dropdown list of Reconcile actions.
2. From this list click Reconcile Record.
3. Hover over the Reconcile action to see the information about the last time the process was ran and the last result.
4. Enter answers for the Primary and Secondary questions that are set for the study.
5. Click the Find button.

Once the Reconcile Record process is complete you will see a screen that lists the record that was reconciled and the message “Finished processing Record”.

Reconcile Code Status

Reconcile Code Status loops through the medical coding terms and re-evaluates the Code Status based on the Code End Level.

1. Hover the mouse over the green Actions menu and select ‘Reconcile.’ This should produce a dropdown list of Reconcile actions.
2. From this list click Reconcile Code Status.
3. Once you click the link, the process will start and run on the screen. When the reconcile process is complete you will see a message that says “Finished processing X Codes.”

Once the Reconcile Record process is complete you will see a screen that lists the record that was reconciled and the message “Finished processing Record”.

Update Name

Update Names updates the primary and secondary names of each record if the primary question and/or secondary question change. The primary and secondary names of a record are the corresponding values of an application’s primary and secondary question.

Note: The process will take a few minutes to run and could take a long time if the trial has several patients.

1. Hover the mouse over the green Actions menu and select ‘Update Names.’
2. Once you click the link, the process will start and run on the screen. When the Update Names process is complete you will see a message that says “Finished updated record names.”

Update Questions

1. Update Questions checks every existing form and adds new questions to the form if they are not currently present. This utility is used for mid-study changes.
   • Hover the mouse over the green Actions menu and select ‘Update Questions.’
     Once you click the link, the process will start and run in the background. When the Update Questions process is complete you will see a screen that lists the subjects that were updated and a message that says “Finished Processing X Record(s)” where X is the number of records that were updated.

Example

• New questions are added on demographics form and we want to reflect the change on the existing form.

The question is also added when you view the form. It is possible to get a form out of sync if the designer adds question without running this utility. Consider the following scenario:

Suppose a study has a form type formA and you release a study modification that adds a new question: ‘Question1a’. If the designer or a user views form2, but not form1 without running updateQuestions the forms will look like this:

form1 (type formA)form2 (type formA)

This can cause issues with the export. If it processes form2 first then it will expect form1 to have the question Question1a. Since it does not, the export will crash.

Update Question Display Utility

The Update Question Display Utility allows you to implement enabled and disabled questions for a trial mid-study.

1. Hover the mouse over the green Actions menu and select ‘Update Question Display’.
2. Click the Continue button to initiate a new update of the display.
3. On the execution page, click the Run button to start the conversion.
4. After selecting the Run button, you will automatically return to your study home page while the utility executes. Check on conversion status by linking back to the utility through the Actions tab to view a progress bar. Once complete, you can review a summary of the conversion results by linking to the View previous results on the Confirmation page.

Utilities Initiated in Form Summary and Form Manager

The following are utilities that can be initiated in Form Summary of the patient casebook or in the Form Manager and are used to address study modifications.

Note: Make sure screen and action permissions have been assigned to the proper roles before following this tutorial.

Update Sequence

The Update Sequence changes a forms sequence number.

1. Forms: Select the forms that require a form sequence update.
2. In the ‘Choose an Action’ dropdown menu, select Update Sequence and click the ‘Go’ button.
3. Enter the desired Sequence Number in the New Value field.
4. Click the Save button.
5. The Update Sequence screen will refresh with the saved values in the Current Value field.

When to Run Utilities

Note: If a dependency was deployed, it should not be removed from the configuration. Rather, the dependency (with its ID and check if blank values unchanged) should be updated to an expression that always returns true; simply add ‘OR 1 == 1′ to the existing expression. This workflow will allow correct reconcile and close of eventually open, existing alerts.

Note: When new questions are added Update Questions should always be the first utility executed.

Note: One or both of the forms must have the “autoCreate” attribute set to false on the Forms-Template tab or all new patients will get both forms.

Note: Once a study is deployed, forms Should NEVER be removed from the Question Layout tab of the Data Architect!

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