Monitor viewEvery value checked against its source as it arrives · Sites 01-06 · LANTERN-OA2 (demo)
Sites at a glance
you monitor sites 01-03 · times are each site's local time| Site | Where the data starts | Need a person | Values checked this week | Last data in | What to know |
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What changes for a monitor
same study, two ways of workingUsual way
- Problems show up weeks later, at the on-site visit.
- You check every value against the chart by hand (100% source data verification).
- Data reaches the EDC a median 8.1 days after the visit.
- Queries go out about 12 days after the fact.
With Nightingale
- Each value is checked against its source and the protocol when it arrives.
- You walk into a visit knowing the few things that need a human look.
- A mismatch becomes one plain question, the same day, with the source attached.
- Many queries never need to exist.
Sources: Tufts CSDD eClinical Landscape Study (8.1 days). The 12 days comes from the synthetic LANTERN-OA2 dataset.
Your next visitSite 01, New York, on Wednesday, August 18. Three items need your eyes. The other 6,915 values since your last visit already matched their source or were converted with the reason saved.
How a value is checked
- 1Read where it was first recorded.
Health record, lab, diary, wrist tracker, IRT, pharmacy log, or a scanned paper sheet. - 2Compare it with Rave and the protocol.
Fixed rules, so the same input always gives the same result. - 3Only the mismatches reach a person.
Each one keeps an audit trail of every step.
Needs your eyes at Site 01
each with its evidence and protocol section01-014, in order
Epic site · each step flagged when it happenedWhat you can skipEvery other value at Site 01 since June 29 matched its source or was converted with the reason saved. Your monitoring plan decides whether you still sample a few by hand.
Source next to Rave
| Participant | What | Source | In the source | In Rave | Status |
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Showing 15 example values from this week. The counts above are for all 4,862.
Most values just matchMatch means the value in Rave is the same as where it was first recorded. Converted means Nightingale changed a unit or a time zone on the way, and the reason is saved with the value. Only a mismatch needs a person.
What the three statuses mean
- Match
Same value in the source and in Rave. Nothing to do. - Converted
Degrees F to C, pounds to kilograms, or a UTC time to the site's local date. The math is shown. - Mismatch
The values differ. A person decides, and the site gets one plain question.
Needs a decision from you
mismatches found by the source checkQueries that never needed to exist
synthetic datasetFix it at the sourceWhen a value is wrong, the question goes to the site with the source attached, so they fix it where it was first recorded and Rave gets the corrected value. In developmentSending straight into Rave's query tool. In a pilot, Nightingale drafts the question and the data manager sends it from Rave.
Open queries
| Query | Question to the site | Raised by | Age | Site's answer |
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Protocol deviations
| Participant | What happened | Grade | Spotted | Usual way | Status |
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Graded the same way every timeSection 13 sorts deviations into important (could affect a participant's safety or the main results) and minor. Nightingale suggests the grade from the protocol; the study team confirms it.
Why the day matters
A deviation spotted the day it happens can still be fixed for the next participant. Found at a visit a month later, the same slip may already have happened again.
What stands between today and lock
per site| Site | Open queries | Unsigned forms | Open deviations | Forms clean and signed |
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Days from last visit to lock
estimateWhy lock can come soonerMost of the cleaning that usually piles up after the last visit happens as the data arrives. What is left at the end is a short list, and you can see it today.