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.

Disabled restricted properties in the Properties panel

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 Yes Yes Yes Yes
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