Learn about the signal management process.
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 Signal Management
The signal management process identifies, tracks, and investigates safety issues that may be related to a medicinal product. SafetyDocs 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 a Literature Review.
- 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 Inbox Items.
- 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, updating labels, 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 (PECs)
- Setting PEC Periods on these PECs
- For PECs requiring further analysis, documenting details and dispositions of Safety Investigations
- Linking PECs and dispositions to Safety Investigations
- Uploading signal management documents and sharing data with other users and groups
Prerequisite
Your Admin must enable Signal Management in your Vault.
Working with Signal Documents
When uploading signal-related documents, use the Signal Management document type and the appropriate subtypes and classifications.
Upload Signal Management documents using the same process as for other document types.