Site data monitoring report

Synthetic Adaptive Platform Trial in Critical Illness

Lahdenpää Yliopistollinen Sairaala (FI-02), Finland. Initiated 20 January 2025, 19 months ago. Report generated 28 August 2026 from data version working, rule set 455d0fba76e0.

What to do this week

Resolve RNG-002: heart rate plausible - 4 records
Heart rate must lie between 25 and 220 beats per minute.
Resolve TMP-001: discharge not before admission - 3 records
Hospital discharge must not precede ICU admission.
Resolve RNG-003: temperature plausible - 2 records
Core temperature must lie between 30 and 43 degrees Celsius.
Resolve XDM-001: death date consistent across domains - 2 records
A participant entered in more than one domain must have the same date of death recorded in every domain.
Resolve STR-003: participant id unique to one site - 1 record
A participant identifier must be used at exactly one site.
Supply the missing randomisation date and time - 2 records
The primary endpoint cannot be calculated for these participants at all, so they are absent from the analysis.
Complete the missing daily ICU records - 20 records
Days with no record are counted as unknown, not as days free of life support, so the primary endpoint is understated for these participants.

This list is the report. Everything below it is the evidence behind these items, and exists so that a query can be answered with “here is why we are asking” rather than “the system flagged it”.

Open findings

Severity	Rule	Name	Findings	Participants
critical	RNG-002	heart_rate_plausible	4	4
critical	TMP-001	discharge_not_before_admission	3	3
critical	RNG-003	temperature_plausible	2	2
critical	XDM-001	death_date_consistent_across_domains	2	1
critical	STR-003	participant_id_unique_to_one_site	1	1
major	STR-001	required_field_present	42	27
major	LOG-001	no_gap_in_daily_records	3	3
major	XDM-002	icu_admission_consistent_across_domains	2	1
major	RNG-001	weight_plausible	1	1

Participants to follow up

Critical findings only, with the identifiers needed to act on them.

Completeness

Proportion of required, human-entered fields carrying a value, by the month of the clinical event. Identifiers and system-stamped dates are excluded: they are always present and would flatter the measure.

form	Aug 2025	Sep 2025	Oct 2025	Nov 2025	Dec 2025	Jan 2026
adverse_events	100.0%	100.0%	100.0%	100.0%	100.0%	NA
daily_icu	98.4%	99.6%	99.4%	97.8%	99.1%	100.0%
outcome_30d	97.0%	100.0%	100.0%	100.0%	100.0%	100.0%
randomisation	100.0%	100.0%	98.1%	100.0%	100.0%	100.0%
screening	99.3%	97.1%	98.3%	98.3%	100.0%	100.0%

Timeliness

Days from the clinical event to entry into the EDC. Read this against the holiday column: entry slows around local public holidays in every country, and a report that ignores that generates queries nobody can act on.

This site against all sites

Compared at the same stage of participation, not on a calendar axis. A site in its third month is compared against every other site’s third month. Comparing a young site against an established one on calendar time penalises it for being young, which helps nobody.

Primary endpoint completeness

Days alive without life support at 30 days is the outcome every adaptive analysis reads. A day with no daily record counts as unknown, not as a day free of life support, so missing records understate the endpoint rather than inflating it.

Measure	Value
Participant-domain records	75.00
Not evaluable (no randomisation date)	2.00
Complete	53.00
Incomplete (some days unknown)	20.00
Died within 30 days	18.00
Total unknown days	36.00
Mean, all records	18.75
Mean, complete records only	16.92

All data in this report is synthetic, generated by the code in this repository from a fixed seed. The site names are invented. This is an independent educational project with no affiliation to any real trial, hospital or research group.