Description:
This Existing Literature & Literature Gap Search Report documents the re-screening of existing citations and, when needed, a literature gap search to align evidence coverage for SoA and S&P AC over a defined period.

• Confirm the report is performed per the referenced protocol and record any deviations with impact justification.
• Define separate search periods for SoA and S&P AC, with justification for appropriateness.
• Justify relevance of each existing literature search reports used for re-screening.
• Re-screen existing citations against the current inclusion/exclusion criteria.
• Decide and document the need for gap search when existing searches do not align with the required end date.
• Apply protocol-based inclusion/exclusion criteria and document Level-1/Level-2 screening decisions.
• Summarize screening outputs with reasons for exclusion and maintain a list of retained citations.

This template is used when prior literature search reports already exist, but you need to confirm their ongoing suitability for your device and fill time-based evidence gaps. It supports systematic re-screening and targeted “gap searches” so your SoA and S&P acceptance criteria evidence remains current and traceable.

Key requirements covered include objective-based screening and transparent gap rationale. A literature gap search extends a previously executed strategy to cover missing dates; it matters because it prevents undocumented evidence gaps. S&P AC means safety and performance acceptance criteria inputs; it matters because it anchors what “acceptable” looks like for comparable devices and alternatives.

At Lexqara, we help you standardise evidence continuity across CER updates by aligning protocols, screening rules, and gap search triggers—supporting clinical documentation, PMS, regulatory submission, and audit readiness. Explore our Resource Center [https://lexqara.com/resource-center/] and Clinical Activities [https://lexqara.com/service/clinical-activities/]. For institutional guidance, use MEDDEV 2.7/1 rev.4 [https://ec.europa.eu/docsroom/documents/17522/attachments/1/translations/]. Download the template and request a short gap assessment.