Review protocol amendment impact ================================ StatMedAnalysis | Original downloadable worksheet | 6 November 2026 Record how a systematic-review protocol change affects completed work. How to use this worksheet Preserve the original protocol and exact change before editing the working version. Record whether screening or results had already been seen. Trace the change to searches, eligibility, extraction and synthesis. Revisit affected decisions and retain an audit trail of the rework. Save a working copy and keep the original blank version. Use public, hypothetical or aggregate information only; do not enter patient identifiers, credentials or confidential records. Keep source evidence in your approved project workspace. Mark unresolved text fields UNKNOWN or NOT REPORTED with a reason; never substitute zero for an unknown count. Project/version __________________ Prepared by role/date __________________ Working fields 1. Protocol identifier and previous version Response/evidence: _________________________________________________________ ___________________________________________________________________________ 2. Exact amendment Response/evidence: _________________________________________________________ ___________________________________________________________________________ 3. Reason and decision date Response/evidence: _________________________________________________________ ___________________________________________________________________________ 4. Evidence already seen Response/evidence: _________________________________________________________ ___________________________________________________________________________ 5. Affected review stages Response/evidence: _________________________________________________________ ___________________________________________________________________________ 6. Previously processed records to revisit Response/evidence: _________________________________________________________ ___________________________________________________________________________ 7. Recheck result and unresolved work Response/evidence: _________________________________________________________ ___________________________________________________________________________ 8. Public explanation location Response/evidence: _________________________________________________________ ___________________________________________________________________________ Hypothetical worked case A fictional review broadens eligible follow-up from six months to three months after screening begins. The team must recheck previously excluded reports and disclose the timing; changing the wording alone is insufficient. Decision rule and limitations Close the amendment only after affected prior work has been reconciled. Describe post hoc changes honestly and retain the prior protocol rather than replacing its history. Decision _______________________ Remaining uncertainty ____________________ Next action ____________________ Owner / review date ______________________ Independent check and discrepancy resolution _______________________________ Official method or reporting reference checked 6 November 2026 https://www.cochrane.org/authors/handbooks-and-manuals/handbook/current/chapter-04 This is an original planning aid, not an official checklist, validated instrument, clinical recommendation or certificate of expert approval. Apply the referenced guidance to the specific design and record any additional requirements.