When you receive updates or additional Case information, you can process and submit the information in a Follow-up Case.
Note: Depending on your Admin’s configuration, object, field, and section labels, lifecycle states, and workflows may differ from the general information on this page. Refer to your organization’s business processes for guidance.
About Follow-Up Cases
When you open a Follow-up Case, Vault creates a new version of the Case and imports all relevant information from the initial version. The new version of the Case enters the Data Entry stage for processing, or the initial case stage defined in your Vault’s Case Processing lifecycle and workflow.
The latest version of the narrative document is copied over from the initial Case. In addition, documents of the following classifications are referenced on the Follow-up Case:
- Case > Source > Adverse Event Report
- Case > Source > Attachment
- Case > Source > Literature
Other document classifications aren’t referenced or copied to the Follow-up Case.
Follow Up on a Closed Case
Once a Case is reported to health authorities, the Case and its related data remain locked to prevent changes and subsequent audit violations.
To add or change information on a Closed Case, you must create a Follow-up Case. In this scenario, Vault changes the state of the initial Case to Superseded.
You can’t create Follow-up Cases from Cases in the Superseded, Nullified, or Voided state or in a lifecycle state assigned to the Deleted state type.
If your Vault is configured for bulk recoding of non-current MedDRA-coded terms, when you run the Run Bulk Recode action, Vault creates a Follow-up Case for each impacted Approved and Closed Case. When the recoding is complete, the Follow-up Case lifecycle state changes to Recoded. For more information, see Bulk Recode MedDRA-Coded Terms on Cases.
Follow Up on an Open Case
When you receive significant follow-up information but don’t have enough time to process and review the new information before reporting the Case, you can create a Follow-up Case and process the new version in parallel with the initial Case.
Note: You can have up to two (2) open versions of a Case at the same time. A Case is considered open when it has not completed processing. This is generally in any state before Approved, Closed, or Superseded.
If the Case updates are non-significant, you can revise an Approved Case before you submit the report to health authorities.
Create a Follow-Up Case
By default, you can create Follow-up Cases for Cases in the Medical Review or Closed state. Your Admin can configure your Vault so this action is available in other states, such as Approved.
Complete the following steps to create a Follow-up Case:
- Go to the Cases tab and then select the Case you want to create a Follow-up Case for.
- On the Case page, expand the All Actions menu, and then select the Create Follow Up Case action.
The action label may appear as Start Revision/Follow-Up, Follow Up (New Version), or a different label depending on your Admin’s configuration.
Result
Vault creates a new version of the Case. If the initial Case is in the Closed state, Vault changes its state to Superseded. If the initial Case had an associated Parent Information Case, Vault also copies that data, along with any new Parent Information from the Inbox Item, to a new version of the Parent Information Case. For more information, see Updating Parent Information in Inbox Item Follow-Up.
Follow-Up on a Localized Case
When a global Follow-up Case is created with the Localization field set to a non-global value, Localized Follow-up Cases are generated for the appropriate locales. See Manage Follow-Up Localized Cases for more information.
Handling an Accidental Follow-Up Case
If a Follow-up Case is created in error, we recommend that you initiate a non-significant Case Revision workflow to Close the Case without generating Submissions.
We do not recommend that you make the Follow-up Case Invalid, because the Invalid state is reserved for when the entire Case (all versions) cannot be submitted to health authorities.
About Case Versions
When you open a new Case, the initial Case version starts at v0.1. When you complete Case processing, Vault assigns the closed Case the next major version number, for example, v1.0.
If you create a Follow-up Case for an open Case, Vault adds one major (+1.0) version number to the Case version. For example, if you create a Follow-up Case for an initial Case version, which is v0.1, the Follow-up Case version during processing is v1.1. When you finish processing and close the Follow-up Case, the version is v2.0.
If you create a Follow-up Case for a closed Case, Vault adds one minor (+0.1) version number to the Case version. For example, if you create a Follow-up Case for a closed Case with v2.0, the Follow-up Case starts at v2.1. When you finish processing and close the Follow-up Case, the version is v3.0.