Sections in This Article
About the Feature
Vault SafetyDocs now supports the Signal Management process based on GVP Module IX guidelines. According to GVP Module IX, Signal Management should be completed in the following order:
- A Signal is detected through a Signal Detection process or Literature Reviews.
- The Signal is assessed and its validity is determined.
- If the Signal is valid, an investigation is performed by reviewing all available data from Cases and Adverse Event Reports.
- Based on the investigation outcome, the Signal is either confirmed or refuted.
- If the Signal is confirmed, further actions are taken such as putting the related product on a watchlist or creating a risk management plan and submitting it to a regulatory authority.
Signal Management in SafetyDocs provides the ability to track Signals after detection and progress through the steps above while maintaining accurate Signal-related records. This feature’s capabilities include:
- Tracking emerging Signals as Product-Event Combinations
- Setting Product-Event Dispositions on these Combinations
- Documenting details and verdicts of Safety Investigations
- Linking Product-Event Combinations and Dispositions to Safety Investigations
The following sections provide more details about Signal Management.
Prerequisite
Your Admin must configure all the steps for this feature. See Enable Signal Management for more information.
Working with Signal Documents
When uploading Signal-related documents, use the Signal Management document type. This includes the following subtypes and classifications:
- Signal Management > Signal Product-Event > Product-Event Disposition
- Signal Management > Signal Investigation > Investigation Summary
- Signal Management > Signal Investigation > Investigation Materials
Upload Signal Management documents using the same process as for other document types. For more information, see Upload a Document to the Library.
Create a Product-Event Combination
A Product-Event Combination establishes a causal relationship between a product and an event as detected in a Signal. In Vault, Product-Event Combinations are made up of the Primary Product Family of the suspected product and the Primary MedDRA term for the reported event.
To create a Product-Event Combination, go to the Product-Event Combinations tab in your Vault and select Create. The following fields appear:
| Field | Description |
|---|---|
| Primary Product Family | The Product Family that is being monitored. Select a Product Family from the dropdown or select the Advanced Search icon to use filters and refine your search. |
| Primary MedDRA term | The MedDRA code for the symptom or adverse event that is being monitored. This can be anywhere in the MedDRA Hierarchy. Select a term from the dropdown or select the Advanced Search icon to use filters and refine your search. |
| Most Recent Disposition | When the most recent Product-Event Disposition enters the Complete state, the system populates this field with the value entered in the Final Disposition field of that Product-Event Disposition. |
| Most Recent Disposition Date | When the most recent Product-Event Disposition enters the Complete state, the system populates this field with the value entered in the Final Disposition Date field of that Product-Event Disposition. |
Product-Event Dispositions Section
As you assess a Product-Event Combination, you can create Product-Event Dispositions to track details about your assessment. You can also record whether the Signal is confirmed, refuted, inactive, or needs to be monitored at that point in time.
To create a Product-Event Disposition, go to the Product-Event Dispositions section of the related Product-Event Combination and select Create. The following fields appear:
| Field | Description |
|---|---|
| Primary MedDRA term | The system populates this field with the value selected in the Primary MedDRA Term field on the related Product-Event Combination. |
| Primary Product Family | The system populates this field with the value selected in the Primary Product Family field on the related Product-Event Combination. |
| Reporting Period | The time period being monitored for events related to this Product-Event Disposition. Select a Reporting Period from the dropdown or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Safety Investigation Reporting Period from the dropdown and manually enter the start and end dates of the Reporting Period. |
| Detection Date | The date when the related Product-Event Combination was detected for investigation. Use the calendar to select the date or enter the date manually. |
| Safety Investigation | If this Product-Event Disposition led to a Safety Investigation, select this investigation from the dropdown or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Safety Investigation from the dropdown and complete the fields as detailed in the Create a Safety Investigation section below. |
| Investigation Type | Select the investigation type for this Product-Event Disposition review. The available options in the picklist include:
|
| Primary Source | The reporting source through which the signal was detected for monitoring. Select a source from the dropdown or select the Advanced Search icon to use filters and refine your search. |
| Final Disposition | Select the final disposition for the chosen Reporting Period from the picklist. The available options include:
|
| Final Disposition Date | The date when the Final Disposition was set. Use the calendar to select the date or enter the date manually. |
Note To support hierarchical browsing of MedDRA Terms for Product-Event Combinations and Product-Event Dispositions, we recommend making some criteria VQL updates in your Vault. Contact your Admin to Enable MedDRA UI Enhancements for Non-Case Coding.
Create a Safety Investigation
Creating a Safety Investigation allows you to record details such as the Reporting Period of events you are investigating, important dates, and Final Dispositions. You can also specify the outcome of your investigation and provide details about relevant data, which is useful for auditing and compliance purposes.
To create a Safety Investigation, go to the Safety Investigations tab in your Vault and select Create. The following fields appear:
| Field | Description |
|---|---|
| Product Family | The Product Family that is being monitored in this investigation. Select a Product Family from the dropdown or select the Advanced Search icon to use filters and refine your search. |
| Primary Source | The reporting source through which the signal was detected for monitoring. Select a Primary Source from the dropdown or select the Advanced Search icon to use filters and refine your search. |
| Reporting Period | The time period being monitored for events related to this investigation. Select a Reporting Period from the dropdown or select the Advanced Search icon to use filters and refine your search. Alternatively, select Create Safety Investigation Reporting Period from the dropdown and manually enter the start and end dates of the Reporting Period and the related Product Family. |
| Detection Date | The date when the related Product-Event Combination was detected for investigation. Use the calendar to select the date or enter the date manually. |
| Start Date | The date when this investigation was started. Use the calendar to select the date or enter the date manually. |
| Summary of Key Data | Enter a summary of the data that led to the outcome of this investigation. This field supports up to 20,000 characters. |
| Validation Outcome | Select whether this investigation led to the detected Signal being confirmed. The available options in the picklist include:
|
| Validation Outcome Date | The date when the Validation Outcome was set on this investigation. The system automatically sets this to the current date whenever the Validation Outcome field is updated. |
| Final Disposition | The final outcome of the Safety investigation. The available options in the include:
|
| Final Disposition Date | The date when the Final Disposition was set on the related Product-Event Disposition. The system automatically sets this to the current date whenever the Final Disposition field is updated. |
