The European Medicines Agency's Guidelines on Good Pharmacovigilance Practices (GVP) - Module VI, outlines the practices marketing authorization holders should follow for the collection, management, and submission of individual reports of suspected adverse reactions.
GVP-VI's Appendix 2 specifies guidelines for medical literature monitoring to ensure compliant and auditable processes. Crypta AI, designed for pharmacovigilance teams, aligns with these guidelines, offering an easy-to-use and compliant tool for literature screening processes.
GVP MODULE VI LITERATURE MONITORING REQUIREMENTS
VI.App.2.1. When to Start and Stop Searching in the Medical Literature
Literature searches should begin when a marketing authorization application is submitted and continue while the authorization is active. In Crypta AI, all searches and screening results are timestamped, and periodic searches are scheduled to ensure comprehensive coverage.
VI.App.2.2. Where to Look
Medline, Embase, and Excerpta Medica are recommended for identifying ICSRs. Datacreds's scientific literature database includes PubMed, Crossref, and DOAJ, along with regional databases, offering a powerful integrated repository for global searches. Users can also upload search results from licensed databases like Embase and EBSCO, with all results de-duplicated.
SEARCH CONSTRUCTION
Guidelines emphasize broad, high-recall searches:
- VI.App.2.3.2. Search Construction: Enter the medicinal product and active substance names.
- VI.App.2.3.3. Selection of Product Terms: Focus on active substances, not just brand names.
- VI.App.2.3.4. Selection of Search Terms: No acceptable loss of recall.
Crypta AI I simplifies database queries by automatically expanding product names into known brand names and synonyms. AI predictions rank and filter articles, ensuring high-recall searches with productivity gains.
VI.App.2.3.5. Limits to a Search
Searches should not be limited to English-only articles. Crypta AI searches articles in any language with automatic language detection, allowing appropriate workflows for non-English content.
SCREENING PROCESS AND OUTPUTS
VI.App.2.4. Record Keeping
Maintain records of search construction, databases used, and search dates. Crypta AI permanently logs screening results, facilitating QC and audits, with all decisions exportable.
VI.App.2.5. Outputs
Retrieve and review full citations, titles, and abstracts. Crypta AI exports full citation details in various formats, supporting direct exports to E2B XML for case processing workflows.
VI.App.2.6. Review and Selection of Articles
Quality control checks should be performed on a sample of literature reviews. Crypta AI supports QC processes with sample checks, batch reviews, and a permanent audit log.
VI.App.2.7. Day Zero
Day zero is the date when minimum information for an ICSR qualifies for submission. Crypta AI timestamps search results and actions, indicating day zero.
VI.App.2.8. Duplicates
Check for duplicate ICSRs in the organization database. Crypta AI automatically de-duplicates search results and links duplicates to their review decisions.
VI.App.2.9. Contracting Out Literature Search Services
Crypta AI supports collaboration and integration with multiple teams through role-based permissions, data export, and a public REST-based API.
VI.App.2.10. Electronic Submission of Copies of Articles
Provide copies of relevant articles and translations upon request. Crypta AI retains and attaches articles and translations to search results for easy retrieval.
CONCLUSIONS
This article reviews the EMA's GVP-VI requirements for pharmacovigilance medical literature monitoring. Datacreds's Crypta AI embeds best practices and compliance requirements into its feature set, ensuring robust and compliant literature screening.
ABOUT CRYPTA AI
Crypta AI is a complete literature screening platform for pharmacovigilance teams. Its flexible workflow, unified scientific database, and unique AI productivity features deliver fast, inexpensive, and fully traceable results for any screening needs. Contact us today for a demo!
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