NoseWorks Study Planner design & govern · the SAP intake
Each part below is owned by one role. Fill in your part, watch the plan update live, then route it for sign-off. Hover the ⓘ on any item for what it means.
Planner v3.7
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Scenario

Prepared by Date
Part A · Clinical Supervisor — Dr. Maggie Mullen
Target & medium, sample rules & eligibility, never-used policy, blinding, validity.

Study definition

Study name / ID i
Target condition i
Sample medium i
Detection method i
Principal Investigator i
Statistician i
Clinical Supervisor i
IRB / approval reference i
Objective / background i

Sample rules

Limits that decide when a vial may be used. Test composition is set by the Statistician.
Max uses — positive iuses
Max uses — healthy iuses
Max uses — benign iuses
Expiration / age limit idays
Never-used-in-training positive i

Sample eligibility

Viability criteria i
Provenance / chain-of-custody fields to record i

Blinding

Who is blinded i
Blinding procedure i

Validity & exclusions

Valid-trial criteria i
Exclusion criteria i
Part B · Statistician
Endpoints, how many tests/dogs and how each test is composed, randomization, analysis & power.

Hypothesis & endpoints

Primary objective / hypothesis i
Primary endpoint i
Secondary endpoints i
Analysis population i
CI method i

Tests, dogs & composition

Dogs in the panel idogs
Panel decision rule i
Total official tests itests
Per test — positive i/ test
Per test — healthy i/ test
Per test — benign i/ test
Per test — blank i/ test
Target-absent — Testing i%
Target-absent — Pre-testing i%
Tests with more than one positive itests
Positives in those tests i/ test

Randomization & order

Randomization method i
Seed / reproducibility note i
Presentation-order handling i

Analysis & power

Expected sensitivity i%
Required threshold i%
Analysis & write-up iweeks
Protocol-deviation handling i
Clustering / non-independence i
Part C · Handler / Trainer — Brian
Estimated weeks per phase, daily/weekly throughput, and time per task.

Phase durations

Study start date i
Setup & readiness iweeks
Training — Phase 1 iweeks
Training — Phase 2 iweeks
Pre-testing — Phase 3 iweeks
Phase 4 — Testing i— weeks
Phase 4 length is calculated from the design (read-only).

Throughput

Runs per day i/ day
Sessions per week i/ wk

Time per task

Handler — per dog-run imin/run
Handler — daily overhead imin/day
Planning estimate of time to commit. Actual hours & pay are tracked in the Tracker (NST).
Plan summary
Live inventory, key numbers, staffing time, and the schedule.

Current sample inventory COORDINATOR

On-hand counts.
On hand — positives ivials
On hand — healthy controls ivials
On hand — benign controls ivials

Key numbers (live)

—
Positive presentations
—
Total dog-runs
—
Official-test days (≈ weeks)
—
Sensitivity 95% CI lower bound
—
Total span (start → data ready)
—
Target-present / absent tests

Samples — have vs. need

Positives are consumed (fresh per test by default); controls are reusable. Training uses additional positives.

Working schedule — staff time

Projected schedule

Diamonds: SAP locked (before official testing) and Data ready.
SAP summary
SAP = Statistical Analysis Plan — the full plan roll-up for review and sign-off.
A read-only roll-up of every part. Red items are not yet filled in.
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