Study Update 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.

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	Name updates	No	N/A	N/A	N/A	N/A	N/A	N/A
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	Delete existing Codelist Items (after production deployment)	No	N/A	N/A	N/A	N/A	N/A	N/A
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	Delete existing Unit Items (after production deployment)	No	N/A	N/A	N/A	N/A	N/A	N/A
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	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
Event Groups	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A
Event Groups	Update Repeating Event Overrides	Yes	Yes	No	Yes	Yes	Yes	Yes
Event Groups	Update the Label, Short Label, or External ID	Yes	Yes	No	Yes	Yes	Yes	Yes
Events	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A
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.
Events	Reorder Events	Yes	Yes	No	No	No	Yes	Yes
Events	Change an Event to Dynamic	Yes	Yes	No	No	No	Yes	No
Forms	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A
Forms	Update the Label, Short Label, or External ID	Yes	Yes	No	No	No	No	No
Forms	Add new 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 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 Repeats	Yes	Yes	No	No	No	No	No
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
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.
Items	Update the Name	No	N/A	N/A	N/A	N/A	N/A	N/A
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
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
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 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 + subject, yes
Schedule	Making an existing form Dynamic	Yes	Yes	No	No	No	No	No
Schedule	Removing a form	Yes	Yes	Yes	No	Yes	Yes	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 + subject, yes
Schedule	Making an existing event/event group dynamic	Yes	Yes	No	No	No	No	No
Schedule	Re-ordering event/event group	Yes	Yes	No	No	No	Yes	No
Schedule	Updates to Event Dates/Queries	Yes	No	No	No	No	No	No
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	No	N/A	N/A	N/A	N/A	N/A	N/A
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