Recruitment monitoring decision rule ==================================== StatMedAnalysis | Original downloadable worksheet | 6 November 2026 Define operational actions when recruitment differs from the plan. How to use this worksheet Specify the monitoring interval and the denominator for each recruitment stage. Set realistic action triggers using project constraints rather than invented benchmarks. Distinguish low screening volume from eligibility or consent problems. Record actions and reassess forecasts without changing scientific eligibility merely to meet targets. 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. Monitoring interval Response/evidence: _________________________________________________________ ___________________________________________________________________________ 2. Screened/eligible/consented counts Response/evidence: _________________________________________________________ ___________________________________________________________________________ 3. Expected stage-specific rates and source Response/evidence: _________________________________________________________ ___________________________________________________________________________ 4. Trigger and required duration Response/evidence: _________________________________________________________ ___________________________________________________________________________ 5. Likely bottleneck Response/evidence: _________________________________________________________ ___________________________________________________________________________ 6. Permitted operational action Response/evidence: _________________________________________________________ ___________________________________________________________________________ 7. Updated forecast and uncertainty Response/evidence: _________________________________________________________ ___________________________________________________________________________ 8. Owner and next review Response/evidence: _________________________________________________________ ___________________________________________________________________________ Hypothetical worked case A fictional project screens 100 people but only 10 meet eligibility. Increasing consent reminders would not solve the main bottleneck; the team first investigates referral pathways and the accuracy of screening assumptions. Decision rule and limitations Use triggers to prompt investigation, not automatic protocol changes. Any eligibility amendment needs its own scientific and governance review. Decision _______________________ Remaining uncertainty ____________________ Next action ____________________ Owner / review date ______________________ Independent check and discrepancy resolution _______________________________ Official method or reporting reference checked 6 November 2026 https://www.consort-spirit.org/ 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.