Sections in This Article
- About Follow-Up Cases
- Create a Follow-Up Case
- Follow-Up on a Localized Case
- Handling an Accidental Follow-Up Case
- About Case Versions
About Follow-Up Cases
When you open a Follow-Up Case, the system 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 types aren’t referenced or copied to the Follow-Up Case.
Follow Up on a Closed Case
When you report a case to health authorities, the case and its related data remain locked to prevent deviations from submitted reports that would trigger an audit violation. To add or change information, you must create a Follow-Up Case.
When you create a Follow-Up Case from a closed case, the system changes the state of the original case to Superseded.
Note You can't create a Follow-Up Case from a Case in the Superseded or Obsolete state.
If your Vault is configured for bulk recoding of non-current MedDRA-coded terms, when the Run Bulk Recode action is run, the system 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 to the original Case.
Tip You can have up to two 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 This is generally in any state before Approved, Closed, or Superseded.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 case to health authorities.
Create a Follow-Up Case
- Go to the Cases tab.
- Locate the Case that you want to add a Follow-Up Case for, and then select the Case name to open it.
By default, the Create Follow Up Case action is only available for Cases in the Medical Review or Closed state. Your Administrator can configure your Vault to make this action available in other states, such as Approved.
- On the Case page, expand the All Actions () menu, and then select the Create Follow Up Case user action. The action label may appear as Start Revision/Follow-Up or Follow Up (New Version), or a different label depending on your Vault’s configuration.
The system creates a new version of the Case. If the original Case is in the Closed state, the system changes the original Case state to Superseded.
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 Case(s) are generated for the appropriate locale(s). 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, the system assigns the closed Case the next major version number, for example, v1.0.
If you create a Follow-Up Case for an open Case, the system 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, the system 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.