This is a ready-to-use plan for systematic pharmacovigilance literature screening, the source of cases most likely to be running informally rather than to a documented schedule. Replace every <<FILL: ...>> placeholder and route it through document control. This content is educational reference, not legal or regulatory advice; confirm the current text of GVP Module VI or your region’s equivalent requirement before relying on it.
Header
| Field | Entry |
|---|---|
| Plan ID | <<FILL: PLAN-ID>> |
| Product(s) / active substance(s) in scope | <<FILL>> |
| Owner | <<FILL: role>> |
| Effective date | <<FILL>> |
| Review cycle | <<FILL: e.g. annual, or on any material change>> |
1. Scope and objective
Define the systematic, documented process <<FILL: COMPANY NAME>> uses to identify potential individual case safety reports and safety signals in the published scientific and medical literature for the products listed above, so that the company can demonstrate it searched, not only that it would have processed a case had one been found.
2. Databases and sources
| Source | Covers | Search frequency |
|---|---|---|
<<FILL: e.g. a major biomedical literature database>> | <<FILL: scope, e.g. peer-reviewed clinical and case literature>> | <<FILL: weekly>> |
<<FILL: additional database if used>> | <<FILL>> | <<FILL>> |
| Centralized regulator literature service (where applicable and in scope) | <<FILL: substances covered by the service>> | Per the service’s published schedule; confirm your own scope obligation is not fully covered |
| Conference abstracts / grey literature (if included in scope) | <<FILL>> | <<FILL>> |
3. Search strategy
- Document the exact search string(s) used per product or active substance, including synonyms, brand and generic names, and relevant event terms.
- Version the search string; any change to it is a controlled change with a documented reason and an assessment of whether historical searches need to be rerun.
- Define the language scope (for example English-language literature, or a broader scope if the company operates in additional-language markets with a documented obligation).
4. Screening procedure
- A trained screener reviews search results against the search strategy on the defined cadence.
- For each result, record a screening decision: excluded (with reason), or included for full-text review.
- For each full-text review, apply the four-element validity test (see ICSR intake procedure
<<FILL: SOP-ID>>); a published case report meeting all four elements is processed as an ICSR with day zero set to the date the company became aware of the publication. - Articles relevant to signal management (case series, epidemiological studies, mechanistic findings) are routed to the signal management procedure
<<FILL: SOP-ID>>even when they do not generate an individual ICSR. - Retain the search results list, the screening decisions, and the rationale for every exclusion.
5. Roles and responsibilities
| Role | Responsibility |
|---|---|
| Literature screener | Runs searches per schedule, applies screening decisions, escalates candidate cases |
| PV scientist | Confirms ICSR determination for screened candidates; routes signal-relevant literature |
| PV quality / QA | Audits that the search cadence in this plan is the cadence actually run |
6. Acceptance criteria
- Every search runs on the defined cadence; a missed search is logged and remediated, not silently skipped.
- Every result is screened with a recorded decision, not only the results that “looked relevant” on a skim.
- Every case-report finding meeting the four elements is processed as an ICSR with day zero from the date of company awareness of the publication.
- The search strategy (databases, terms, cadence) is reviewed at the defined cycle and after any material product or regulatory change.
7. References
EU GVP Module VI, section on literature review requirements. ICH E2D(R1), Post-Approval Safety Data Management (case-management definitions applicable to literature-sourced cases). Applicable national requirements for systematic literature review outside the EU/US, confirmed per market.
Confirm the current version of each reference before issue.
8. Screening log
| Date | Database | Search string version | Results screened | Included for full review | ICSRs generated | Signals routed |
|---|---|---|---|---|---|---|
<<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> | <<FILL>> |
Filled specimen
A completed weekly screening log entry for an example product. Illustrative only.
| Date | Database | Search string version | Results screened | Included for full review | ICSRs generated | Signals routed |
|---|---|---|---|---|---|---|
| 04 Aug 2026 | Primary biomedical database | v3.2 | 61 | 4 | 1 (published case report of a rash meeting all four elements) | 1 (a small case series on a possible cardiac signal, routed to signal management for qualitative review) |
The single ICSR here came from a full-text case report, day zero set to the date the screener identified the article, not the article’s publication date. The case series did not itself describe a company product’s patient with a reportable event in the traditional sense, but it was still routed to signal management, because literature is a source for the signal workflow as much as it is a source of individual cases, and a screening process that only asks “is this an ICSR” misses that second obligation.
Common inspection findings this plan prevents
- No documented search strategy or database list, so the company cannot demonstrate a systematic search occurred.
- The search cadence in the SOP does not match records of when searches were actually run.
- A case report is found in the literature but processed with day zero set to the publication date rather than the date of company awareness.
- Signal-relevant literature (case series, epidemiology) is screened only for ICSR content and never routed to signal management.
How to adapt this plan
- Set your actual database(s), search strings, and cadence in sections 2 and 3, not a generic placeholder list.
- Confirm whether a centralized regulator literature service covers your substances, and document precisely what remains your own obligation.
- Point the cross-references in section 4 to your real ICSR intake and signal management procedures.
- Confirm every regulation in section 7 against the current published version before issue.