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How do I trace my review protocol to the final report for reproducibility?

November 2, 2026
systematic review protocolreproducibilityPRISMA 2020deviation trackingresearch reporting

Build a traceability table that maps each protocol element—eligibility, search, outcomes, and synthesis plan—to its report section and logs every deviation with a justification. The table lets a reader reconstruct why each decision was made and see which changes were declared.

Set up the table

Create one row per protocol element. Use columns for the protocol element, the planned specification, the corresponding report section, the final specification, a deviation flag, and the justification. Keep the protocol version and date in the header so readers know which plan you are tracing.

Trace each element

  1. List the eligibility criteria (population, intervention, comparator, outcomes, study designs) and point each to the report section that states it; mark any criterion added, dropped, or reworded after the protocol as a deviation with its reason.
  2. Record the search plan—databases and sources, search strategy, and record management—and map it to the report's search description, following the Cochrane Handbook's guidance on documenting searches and managing records; flag any source or strategy change.
  3. Map each prespecified outcome to where the report defines and reports it, and note any outcome that was added, removed, or reclassified.
  4. Point the synthesis plan (which studies are combined and how results are summarized) to the methods and results sections, and log any change in the analysis approach.

Flag undeclared changes

Compare the planned and final columns row by row. Any difference without a matching justification is an undeclared change; add it to a disclosure list so the report states what changed and why. Use the PRISMA 2020 checklist and flow diagram to confirm the report covers the items your table references.

Check the references

Verify each cited source against the original, cite direct sources where possible, and check for retractions, as the ICMJE recommendations advise. Record the verification in the table so the source list is traceable too.

Final pass

Read the table against the finished report. Every protocol element should have a report location, and every deviation should carry a justification or appear on the disclosure list.

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