Summary

Study Modifications, also known as Mid-Study Changes, Study Amendments, etc., often involve the removal or addition of portions of the casebook which do not immediately affect existing records or 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 as well as how to implement these various changes.

Table of Contents

• Utilities
  • Insert Forms
  • Move Form
  • Move Record
  • Reconcile
  • Reconcile Form
  • Reconcile Record
  • Reconcile Code Status
  • Refresh Metadata
  • Rename Form
  • Update Form Config
  • Update Names
  • Update Question Type
  • Update Questions
  • Enable/Disable Questions
  • Update Sequence
• When to Run Utilities

Note: Always test your changes in the design/test/approve environment(s) before loading to production!

The following is a quick list of things you should not or cannot change once a study is loaded to production:
	
You cannot change from a partial date to a full date.
You cannot change the date format of a full date question.
You should not modify a partial date field to become more restrictive, but can modify it to become less restrictive. For example, you can modify the partial date format dd[UN]-MMM[UNK]-yyyy to allow an unknown year. However, you should not modify it to prevent an unknown month.
You cannot remove a form or question from the study configuration. If you need to hide a form, set 'autoCreate' in the Forms Template to false. If you need to hide a question, you can remove it from the display with the Active configuration in the Display tab of the Data Architect file set to false, and run the Update Question Display Utility. You can delete forms from the casebooks but they should remain in the study configuration.

Utilities

The following utilities are typically used to address the modifications mentioned above. All action permissions will be edited in the Roles tab in the Data Architect file.

Insert Forms

Insert Form inserts a form into an existing subject. The inserted form can be either a static or dynamic form.

1. Custom Actions: Enter ‘Insert Form’.
2. Actions Required: Enter ‘insertForm’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Move Form

Move Form moves a form from one parent form to another.

1. Custom Actions: Enter ‘Move Form’.
2. Actions Required: Enter ‘moveForm’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Move Record

Move Record moves a record (subject) from one tool (site) to another within the site network.

1. Custom Actions: Enter ‘Move Record’.
2. Actions Required: Enter ‘moveRecord’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Reconcile

Reconcile loops through all records (subjects) to re-evaluate scripts and 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 subjects at the all sites level.

1. Actions: Enter ‘Reconcile’.
2. Actions Required: Enter ‘reconcile’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

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

Reconcile Form

Reconcile Form loops through the specified records and re-evaluates the dependencies and/or assignments for the specified form. Reconcile Form also updates Visit Manager settings and questions with newly assigned medical coding dictionaries.

1. Custom Actions: Enter ‘Reconcile Form’.
2. Actions Required: Enter ‘reconcileForm’.
3. Screens Required: Enter ‘reconcileForm’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Reconcile Record

Reconcile Record loops through the specified subjects and re-evaluates the dependencies and/or assignments for the specified subject.

1. Custom Actions: Enter ‘Reconcile Record’.
2. Actions Required: Leave this field blank.
3. Screens Required: Enter ‘reconcileRecord’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

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. Actions: Enter ‘Reconcile Code Status’.
2. Actions Required: Leave this field blank.
3. Screens Required: Enter ‘reconcileCodeStatus’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Refresh Metadata

Refresh MetaData loops through the specified address and causes the MetaData of a particular parent form to be re-evaluated. It is typically used after a form has been moved. 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.
In some instances when a question is added to a form, Refresh Metadata should to be executed.
Run the utility at the point the discrepancy occurs.

1. Custom Actions: Enter ‘Refresh MetaData’.
2. Actions Required: Enter ‘refreshMetaData’.
3. Screens Required: Enter ‘refresh MetaData’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Rename Form

Rename Form loops through the user-selected subjects and changes the name of the selected form by overriding the form name specified in the Data Architect.

1. Custom Actions: Enter ‘Rename Form’.
2. Actions Required: Enter ‘renameForm’.
3. Screens Required: Enter ‘renameForm’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Update Form Config

Update Form Config allows a form’s alias and/or type to be changed.

1. Custom Actions: Enter ‘Update Form Config’.
2. Actions Required: Enter ‘updateFormConfig’.
3. Screens Required: Enter ‘updateFormConfig’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Update Names

Update Names loops through all records and updates the primary and secondary names of each record if the primary question and/or secondary question change. The primary and secondary questions are used as a subject identifier.

1. Custom Actions: Enter ‘Update Names’.
2. Actions Required: Enter ‘updateNames’.
3. Screens Required: Enter ‘updateNames’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Update Question Type

The Update Question Type changes a question’s question type or answer options.

1. Custom Actions: Enter ‘Update Question Type’.
2. Actions Required: Enter ‘updateQuestionType’.
3. Screens Required: Enter ‘chooseQuestions’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Update Questions

Update Questions loops through all records, checks every existing form, then creates and adds new questions to the form if they are not currently present.

1. Custom Actions: Enter ‘Update Questions’.
2. Actions Required: Leave this field blank.
3. Screens Required: Enter ‘updateQuestions’.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

Enable/Disable Questions

The Update Question Display utility allows you to enable and disable questions for a display mid-study. Assign the following permissions to designate a role with the ability to run the display utility:

1. Custom Actions: Enter ‘Update Question Display’.
2. Actions Required: Enter ‘updateQuestionDisplay’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

With permissions in place, the Actions tab on your study home page now contains an Update Question Display menu option.

Update Sequence

The Update Sequence utility allows you to reorder forms from the form summary and form manager. Assign the following permissions to designate a role with the ability to run the update sequence utility:

1. Actions: Enter ‘Update Sequence’.
2. Actions Required: Enter ‘updateSequence’.
3. Screens Required: Leave this field blank.
4. Select the Roles that should be able to perform this action by placing an ‘X’ in the appropriate columns.

With permissions in place, the Choose An Action menu on the Form Summary and Form Manager now contains an Update Sequence menu option.

When to Run Utilities

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