Clinical Audit Sampling Planner

An interactive planner to design statistically defensible, pragmatic clinical audits. Capture sampling parameters, choose randomization methods, record the sampling frame and strata, save a reusable data-collection template, and follow an analysis checklist and governance-ready reporting template. The form includes clear guidance, a sample-size formula with worked example, and structured fields you can save for reuse.

Interactive Tool

Clinical Audit Sampling Planner

Plan a defensible clinical audit

Use this planner to capture the key sampling decisions you need to run a defensible clinical audit: population definition, sampling frame, expected proportion, confidence level, margin of error, randomization method, and stratification. The form collects structured details you can save and reuse. Guidance and a common sample-size formula are provided below so you can estimate a sample size and document the calculation for governance.

Quick sample-size formula for a proportion

1) Calculate the initial sample size (n0) for an infinite population: n0 = Z^2 * p*(1-p) / e^2

  • Z is the Z-score for your chosen confidence level (1.645 for 90%, 1.96 for 95%, 2.576 for 99%).
  • p is the expected proportion as a decimal (use 0.5 when uncertain—most conservative).
  • e is the desired margin of error as a decimal (for 5% margin use 0.05).

2) Apply finite population correction when population N is small: n = n0 / (1 + (n0 - 1)/N)

Worked example: N=2,000; p=0.5; confidence=95% (Z=1.96); e=0.05.

n0 = 1.96^2 * 0.5*0.5 / 0.05^2 ≈ 384.16 → n ≈ 384 / (1 + (383/2000)) ≈ 324

Use the fields below to record inputs and your final sample-size decision. If you'd like automated calculation or a random-number generator, see the notes at the end of this form.

Give this audit a clear name (e.g., 'Medication Reconciliation Compliance - Q3 2026').
Describe exactly what is being measured or observed (inclusion/exclusion criteria, numerator/denominator if applicable).
Enter the total eligible population (if known). Leave blank if unknown and explain why in the sampling-frame field.
Estimated % expected to meet the criterion (enter 50 for conservative estimate). Use whole numbers (e.g., 50).
Choose the confidence level for your sample-size calculation.
Acceptable margin of error (e). Common choices: 5 for ±5%.
Choose 'Yes' when population N is not very large relative to the sample (helps reduce required sample).
Enter the final sample size you will audit after applying FPC and any practical constraints. Use the formula in guidance or an external calculator. Record how you adjusted the number if necessary (e.g., rounding, resource constraints).
Describe the data source or list you'll sample from (e.g., EHR query name, date range, wards included). Note any known gaps or duplicates.
Select the method you will use to pick records or patients.
If using a reproducible random sample, record the software and seed or the method (e.g., 'R sample() with seed=20260830', 'Excel RAND sort').
Choose 'Yes' if you will sample within strata (e.g., wards, clinician type).
If stratifying, list strata, stratum sizes (N_i), and how many records to sample per stratum (n_i).
Write the exact steps an auditor will follow to produce the sample (queries, sorts, indexing, how to handle ineligible records). This is critical for reproducibility and governance.
Paste the CSV column headers or list the variables you will collect (e.g., patient_id, encounter_date, criterion_met Y/N, notes). Use the same headers when collecting data to simplify analysis.
Enter an approximate start date or week (format: YYYY-MM-DD or 'Week of ...').
Check items to include in your analysis and governance report:
Paste or outline the reporting sections you will use for governance (e.g., Background, Methods, Results, Interpretation, Actions).
Record practical constraints that might affect the plan (staffing, access to systems) and how you'll mitigate them.
Record versioning notes and approvals (who approved the plan and when).
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