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
Note: You can create Signal Detection Plans to provide a centralized area for monitoring product safety and the methodology for performing signal detection for a Product Family, Aggregate Reporting Group, or Products of a Therapeutic Area.
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.