Safety Letter Management Solution
A Safety Letter Management solution is essential for tracking pharmacovigilance (PV) and other product safety notices because it ensures the continuous monitoring of the safety profile of drugs or other medical products during clinical trials as well as on the market. The primary goals of the Safety Letter Management solution are to store and provide information about safety notices related to adverse product events. The Safety Letter Management solution within TI is just one piece of a multi-layered safety system.
What does the solution do?
- Utilizes Site Module to build out investigative sites, add contacts, and assign acknowledgment responsibility to contact(s) at investigative sites.
- Leverages acknowledgments in the system to ensure all safety event-related documents have been viewed and acknowledged by the appropriate site personnel
- Offers an optional workflow and document management process to author, collaborate on, and approve letters for distribution.
- Full 21CFR11 compliant audit trail, tracking user, document, and workflow actions
- Provides streamlined, configurable folder structure for storing and managing safety letters within the system.
- Provides flexibility to include a mechanism for external distribution of safety letters via attachment, tracked in the communication module, for sites or users who will not be acknowledged within the system.
- Leverages configuration to support storage of over 250 file types
- Documents are stored with consistent naming conventions based on configurable metadata, allowing safety/clinical team members and site personnel to easily identify the study, safety database ID, event date, and other relevant information simply by viewing the document name.
- Provide notification and direct document links to site personnel when they are required to acknowledge a document.
- Provides a central view for all outstanding, overdue, and completed acknowledgments for sites and for sponsor/CRO personnel.
- Report to show compliance data by investigative site.
- Mechanism for clinical/safety personnel to cancel, resend, and/or send reminders to responsible site personnel directly from the document.
System/Technical Requirements
- Standard Trial Interactive browser requirements apply to the Safety Letter Management Solution.
- It is assumed that the system has no practical limit to the number of authorized users who are asked to acknowledge documents and/or are accessing them within the room.
- This solution has TransPort Translations enabled to easily request a certified translation of any documentation.
- This solution can perform a Quality Review for oversight.
High-level technical capabilities:
- Users can view, and modify metadata on documents within a workflow if desired and configured
- Users can Copy/move documents between rooms if desired and configured
- Users can perform translation requests for certified translations if desired and configured
- Users can run reports on Inventory, KPIs, User Access
- Ability to access Audit Trail
- Ability to add or remove user access
- Ability to designate site contact as required to perform acknowledgments in the system.
- Ability for Sites to be chosen based on Site-level metadata search when sending acknowledgment requests, with users auto-populated based on their acknowledgment designation in their contact profile. Additional users can be added as/if desired.
- Ability to send acknowledgment documents via built-in email mechanism to one or multiple site contact personnel, with tracking in the communications outbox module.
Solutions available for interoperability:
- Translations Portal
- GlobalLearn
- TI Connector
- eTMF
- eISF