Description:
This Clinical Data Search Protocol defines a systematic approach for collecting clinical evidence to support SoA, AC, and S&P objectives.
• Define objectives for state of the art (SoA), acceptance criteria (AC), and safety & performance (S&P) evidence.
• Specify justified search periods per objective (SoA, AC, S&P).
• Document exact queries with connectors, limits, and date ranges for reproducibility.
• Apply PICO-based research questions and reproducible search queries.
• Use defined search databases (e.g., Embase, PubMed, Cochrane, trials registries).
• Set global search limitations (article type, language, humans) per objective.
• Remove duplicates within and across databases using defined rules.
• Perform Level-1/Level-2 screening with documented inclusion/exclusion criteria.
• Include vigilance/recall searches (e.g., FDA MAUDE/recalls) and document outcomes.
• Produce search reports to feed CER/PMCF and related deliverabl

This protocol is used to plan and justify literature, vigilance, and recall searches so clinical evidence collection is consistent, reproducible, and aligned with MEDDEV 2.7/1 rev.4. It supports updates to clinical evaluation and post-market activities by defining what to search, where, and how results will be screened and recorded.

Key requirements covered include traceable search logic and defensible screening. PICO means structuring research questions by population, intervention, comparator, and outcomes to drive targeted queries; it matters because it prevents gaps and irrelevant hits. PRISMA is a reporting framework to summarize screening flow; it matters because it improves transparency of inclusion decisions.

At Lexqara, we help you operationalize this protocol into controlled templates, reviewer-ready search reports, and CER/PMCF evidence packages—covering clinical documentation, PMS, and regulatory submission support. Explore our Resource Center [https://lexqara.com/resource-center/] and our Regulatory Strategy service [https://lexqara.com/service/regulatory-strategy/]. For institutional guidance, see European Commission Guidance MEDDEVs [https://health.ec.europa.eu/document/download/c1a6aa0b-d8c8-498b-8ed4-9f3c6211896d_en]. Request a short gap assessment of your current search approach.