Post Go-Live Change Impact and Restrictions

After you publish the initial version of your Casebook Definition, Vault prevents you from making certain changes in any later versions you may create. If you were to make these changes, it could cause errors during the casebook amendment process.

For disallowed changes, Vault disables the appropriate control in the Studio Properties panel. In the image below, the Name, Event Group Type, and Repeating property fields are all disabled, even though the Properties panel is in Edit mode.

Development Environment Data Conflict for Permitted Changes: In some cases, data existing in your development (DEV) or test (TST) environment conflicts with changes you may attempt to make in that environment, even though these changes are not restricted. When this happens, the system displays an error dialog, with a message that describes the issue. To resolve this error, delete existing casebooks in the environment and try again.

The table below describes various post go-live configuration update scenarios.

Category	Update Scenario	Post Go-Live Changes Allowed	Requires New Version	Destructive Change	Breaks Signature	Unfreezes Data	Unsubmits Forms	Breaks SDV/DMR	Recommendations & Comments
Codelists	Code or Name updates	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Codelist Item with the desired name and hide the original
Codelists	Label updates	Yes	Yes	No	Yes	Yes	Yes	Yes	This only breaks signature, form status, etc., if the Codelist Label option being changed has been selected.
Codelists	Remove or delete existing Codelist Items	No	N/A	N/A	N/A	N/A	N/A	N/A	Use the hide function to hide the Codelist Item
Codelists	Hide existing Codelist Items	Yes	Yes	No	No	No	No	No	If the Codelist Item you’re hiding has been selected for the Item in Data Entry, EDC won’t remove that data. The Codelist Item will only become unavailable for future selection. Upon changing the data from the previously hidden choice to a new option, the signature, SDV, etc., will be broken.
Codelists	Make existing Codelist Items visible (unhide)	Yes	Yes	No	No	No	No	No
Codelists	Reorder Codelist Items	Yes	Yes	No	No	No	No	No
Codelists	Add new Codelist Items to the Codelist	Yes	Yes	No	No	No	No	No	This only impacts existing data if an existing Form is resubmitted with a new Codelist Item selected.
Codelists	Change the Control Type (picklist, radio buttons, etc.)	Yes	Yes	No	No	No	No	No
Units	Update conversions	No	N/A	N/A	N/A	N/A	N/A	N/A	We recommend that you hide the original Unit Definition and add a new one with the updated conversion formula.
Units	Label updates	Yes	Yes	No	Yes	Yes	Yes	Yes	This only breaks signature, form status, etc., if the Unit Label option being changed has been selected.
Units	Remove or delete existing Unit Items	No	N/A	N/A	N/A	N/A	N/A	N/A	Use the hide function to hide the Unit Item
Units	Change the default Unit Items	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Unit Item with the desired default
Units	Hide existing Unit Items	Yes	Yes	No	No	No	No	No	If the Unit Item you’re hiding has been selected for the Item in Data Entry, EDC won’t remove that data. The Unit Item will only become unavailable for future selection. Upon changing the data from the previously hidden choice to a new option, the signature, SDV, etc., will be broken.
Units	Make existing Unit Items visible (unhide)	Yes	Yes	No	No	No	No	No
Units	Reorder Unit Items	Yes	Yes	No	No	No	No	No
Units	Add new Unit Items to the Unit	Yes	Yes	No	No	No	No	No	This only impacts existing data if an existing Form is resubmitted with a new Unit Item selected.
Units	Change the Abbreviation for a Unit Item	Yes	Yes	No	No	No	No	No
Event Groups	Make a non-repeating Event Group into a repeating Event Group (non-repeating to repeating)	Yes	Yes	No	No	No	No	No
Event Groups	Reorder Event Groups	No	N/A	N/A	N/A	N/A	N/A	N/A	Moving events across event groups is a destructive change that is not supported as this breaks the Event Group - Event relationship. Moving an Event is the equivalent of removing it from one Event Group and adding it to another one
Event Groups	Make a repeating Event Group into a non-repeating Event Group (repeating to non-repeating)	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new, non-repeating Event Group
Event Groups	Make a scheduled Event Group into an unscheduled Event Group and vice versa	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new, scheduled or unscheduled Event Group
Event Groups	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Event Group with the desired name
Event Groups	Update Repeating Event Overrides	Yes	Yes	No	N/A	Yes	Yes	Yes
Event Groups	Update the Label, Short Label, or External ID	Yes	Yes	No	N/A	Yes	Yes	Yes
Event Groups	Change a non-dynamic Event Group to Dynamic	Yes	Yes	No	No	No	Yes	No	You must create or revise an appropriate Add Event Group rule to add dynamic Event Groups to your study design
Events	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Event with the desired name
Events	Add or update Event Windows	Yes	Yes	No	No	No	Yes	Yes	This only applies to queries (both existing and new) if the query results in a data change from the site. Note that when removing Event Windows, you may need to delete DEV and TST environment casebooks that were created using the previous Event Window, or an error will occur.
Events	Add or update Visit Method	Yes	Yes	No	No	No	No	No	Can be added to existing events using Edit Event Details after the retrospective amendment job is complete.
Events	Reorder Events	Yes	Yes	No	No	No	Yes	Yes
Events	Change an non-dynamic Event to Dynamic	Yes	Yes	No	No	No	Yes	No
Events	Change the Event Type to Log	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Event with the desired Event Type
Forms	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Form with the desired name
Forms	Update the Label, Short Label, or External ID	Yes	Yes	No	No	No	No	No
Forms	Change a non-dynamic Form to Dynamic	Yes	Yes	No	No	No	No	No	You must create or revise an appropriate Add Form rule to add dynamic Forms to your study design.
Forms	Add new Form Link relationships	Yes	Yes	No	No	No	No	No
Forms	Remove existing Form Link relationships	Yes	Yes	No	No	No	No	No
Forms	Change existing Form Link Text	Yes	Yes	No	Yes	Yes	Yes	Yes
Forms	Change the Form Link Item	Yes	Yes	Yes	No	No	No	No
Forms	Add new Item Groups to the Form	Yes	Yes	No	Yes	No	Yes	Yes
Forms	Remove existing Item Groups to the Form	Yes	Yes	Yes	No	No	No	No	While this action doesn’t unfreeze the Form, it does unfreeze the Subject and the Event.
Forms	Add new Items to the Form	Yes	Yes	No	Yes	No	Yes	Yes
Forms	Remove existing Items from the Form	Yes	Yes	Yes	No	No	No	No	While this action doesn’t unfreeze the Form, it does unfreeze the Subject and the Event.
Forms	Make a non-repeating Form into a repeating Form	Yes	Yes	No	No	No	No	No
Forms	Make a repeating Form into a non-repeating Form	No	N/A	N/A	N/A	N/A	N/A	N/A
Forms	Increase or decrease Repeat Maximums	Yes	Yes	No	No	No	No	No	When decreasing the repeat maximum, all existing Form records that exceed the new maximum are retained.
Forms	Increase or decrease Repeat Minimums	Yes	Yes	No	Yes	No	No	No	When decreasing the repeat minimum, all existing Form records that exceed the new minimum are retained. New instances of repeating non-dynamic Forms are created automatically when the Repeat Minimum is increased.
Forms	Move the Form to a different Event	Yes	Yes	Yes	Yes	Yes	Yes	Yes
Forms	Change the order of Forms in an Event	Yes	Yes	No	No	No	No	No
Forms	Mark an existing Form as Restricted	No	N/A	N/A	N/A	N/A	N/A	N/A	This isn’t allowed. Instead, you must create a new Form.
Forms	Make a Restricted form Unrestricted	No	N/A	N/A	N/A	N/A	N/A	N/A
Item Groups	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Item Group with the desired name
Item Groups	Update the Label	Yes	Yes	No	No	No	No	No
Item Groups	Increase the Repeat Maximum	Yes	Yes	No	No	No	No	No
Item Groups	Decrease the Repeat Maximum	Yes	Yes	No	No	No	No	No	You can decrease the Repeat Maximum for an Item Group, but the change will only apply to new instances of the Item Group. To apply this update to existing forms, you must reset the Form manually.
Item Groups	Change Default Data	Yes	Yes	No	No	No	No	No	This can be done as net new. If you’re changing an existing default data rollout, the Form will need to be reset.
Item Groups	Change the order of Item Groups in a Form	Yes	Yes	No	No	No	No	No
Items	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Item with the desired name
Items	Update the Label, Short Label or External ID	Yes	Yes	No	No	Yes	No	No	This can possibly change the meaning of the data.
Items	Change the item’s Data Type	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Item with the desired data type
Items	Change the Item’s Codelist or Unit	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Item with the desired Codelist or Unit
Items	Move an Item within the same Item Group	Yes	Yes	No	No	No	No	No
Items	Move an Item to a different Item Group	Yes	Yes	Yes	Yes	No	Yes	No
Items	Increase the Length/Precision	Yes	Yes	No	No	No	No	No
Items	Decrease the Length/Precision	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Item with the desired Length/Precision
Items	Change the Destination for a Derived Item	Yes	No	No	No	No	No	Yes
Items	Change the Source for a Derived Item	Yes	No	No	No	No	No	No
Items	Changes to the Allow Unknown property	Yes	Yes	No	No	No	No	No
Items	Updating an Item Dependency (Progressive Display)	Yes	Yes	No	No	No	No	No	An item dependency doesn’t re-evaluate unless you change the data in the Controlling Item. At that point, Vault would prompt the user about data being removed.
Labs	Create a new Lab Panel	Yes	Yes	No	Yes	No	Yes	No
Labs	Add a new Analyte	Yes	Yes	No	Yes	Yes	Yes	Yes
Labs	Remove an Analyte	Yes	Yes	Yes	No	No	No	No
Labs	Update the Name of the Lab Panel	No	N/A	N/A	N/A	N/A	N/A	N/A
Labs	Update the Label or External ID for the Lab Panel	Yes	Yes	No	No	No	No	No
Labs	Update the Conversion Factor	Yes	No	No	No	No	No	No	An update to Conversion Factors that causes submitted data to go from in range to out of range will break the signature. This can only be done in Studies using Global Labs.
Rules	Email Groups (being assigned to rule actions)	Yes	No	No	No	No	No	No
Rules	System Queries (Incl. Ranges)	Yes	No	No	No	No	No	No	This only applies to queries (both existing and new) if the query results in a data change from the site.
Rules	Rules (User Defined and comparison)	Yes	No	No	No	No	No	No	This only applies to queries (both existing and new) if the query results in a data change from the site.
Schedule	Review Plan requirement changes	Yes	No	No	No	No	No	Yes	Review status of reviewed objects will be retained if going from Optional -> Optional / Required or Required -> Optional/Required. Only broken if No Review -> Optional/Required
Schedule	Signatures Update	Yes	No	No	Yes	No	No	No
Schedule	Addition of New Forms	Yes	Yes	No	Yes	No	No	No	Signature for the Event and Subject is broken
Schedule	Removing an Event Group	Yes	Yes	Yes	No	Yes	Yes	Yes
Schedule	Removing an Event	Yes	Yes	Yes	No	Yes	Yes	Yes
Schedule	Removing a Form	Yes	Yes	Yes	No	Yes	Yes	Yes
Schedule	Re-ordering Event Groups	No	N/A	N/A	N/A	N/A	N/A	N/A	Create a new Event Group and remove the other from the schedule
Schedule	Re-ordering Events in the same Event Group	Yes	Yes	No	Yes	No	No	Yes
Schedule	Re-ordering Forms	Yes	Yes	No	No	No	No	No
Schedule	Adding an Event / Event Group	Yes	Yes	No	Yes	No	Yes	No	Signature for the Event and Subject is broken
Schedule	Updates to Event Dates/Queries	Yes	No	No	No	No	No	No
Schedule	Re-add deleted dynamic definition for a form, event, or event group	Yes	Yes	No	No	No	No	No	Vault automatically retrieves the previous relationship settings and re-applies the dynamic property.
Settings	Casebook Variables	Yes	Yes	Yes	No	No	No	No
Settings	Creating Assessments	Yes	No	Yes	No	No	No	No
Settings	Enable Protocol Deviations	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Adding new Protocol Deviations Categories / Sub-Categories	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Editing Protocol Deviation relationships	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Enable Other Specify - ILB	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Enable Query Team Restrictions/Query Teams for System Queries	Yes	No	No	No	No	No	No
Settings	Query on Out of Range Event Dates	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Enable Additive Review	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Enable Subject Status Rollback Date	Yes	No	N/A	N/A	N/A	N/A	N/A
Settings	Subject ID Gen: Type, Ranges	No	N/A	N/A	N/A	N/A	N/A	N/A	Cannot be done if there are existing sites in the environment you are deploying to
Studio External	Labs Study General: Allow Site Overrides for Lab Normals	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Pending Lab Locations	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Lab Normal Entry in Form	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Default Day and Month for Age calculations	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Disable Unit selection for Lab Results when Lab Normals are present	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Fire Out-of-range Queries by Default	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Query Lab Units Do Not Match	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Query Lab Age Calculation	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Query For Missing Lab Results	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Enable Clinical Significance	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Update / Add options to Study Clinical Significance Codelist	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Labs Study General: Remove options to Study Clinical Significance Codelist	Yes	No	N/A	N/A	N/A	N/A	N/A
Studio External	Email Groups assignment (users within groups)	Yes	No	N/A	N/A	N/A	N/A	N/A	This can be done in EDC Tools at any time.
Studio External	Review plan assignments to sites / casebooks	Yes	No	N/A	N/A	N/A	N/A	N/A	This can be done in EDC Tools at any time.
Safety	Update general settings	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Add new form configuration	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Remove existing form configuration	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Modify existing inclusion rules	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Add new mappings within existing form configuration	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Remove existing mappings within existing form configuration	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Change existing mappings within form configuration	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Add new value translations	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Remove existing value translations	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs
Safety	Modify existing value translations	Yes	No	N/A	N/A	N/A	N/A	N/A	Any impacted safety cases will have a follow-up message generated after go-live takes place and the first “full scan” job runs