| Severity | Rule | Name | Findings | Participants |
|---|---|---|---|---|
| critical | RNG-002 | heart_rate_plausible | 5 | 5 |
| critical | XDM-003 | vital_status_consistent_where_windows_agree | 5 | 3 |
| critical | STR-004 | single_randomisation_per_domain | 3 | 2 |
| critical | RNG-003 | temperature_plausible | 2 | 2 |
| critical | LOG-002 | not_alive_after_death | 1 | 1 |
| critical | STR-003 | participant_id_unique_to_one_site | 1 | 1 |
| critical | TMP-004 | ae_onset_before_randomisation | 1 | 1 |
| major | STR-001 | required_field_present | 813 | 108 |
| major | LOG-001 | no_gap_in_daily_records | 7 | 7 |
| major | XDM-002 | icu_admission_consistent_across_domains | 1 | 1 |
Site data monitoring report
Synthetic Adaptive Platform Trial in Critical Illness
Askerup Hospital (DK-11), Denmark. Initiated 08 April 2024, 28 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 - 5 records
Heart rate must lie between 25 and 220 beats per minute.Resolve XDM-003: vital status consistent where windows agree - 5 records
Where two domains share the same 30-day assessment date, they must report the same vital status.Resolve STR-004: single randomisation per domain - 3 records
A participant must be randomised at most once within any single domain.Resolve RNG-003: temperature plausible - 2 records
Core temperature must lie between 30 and 43 degrees Celsius.Resolve LOG-002: not alive after death - 1 record
A daily record must not report the participant alive on a date after the recorded date of death.Resolve STR-003: participant id unique to one site - 1 record
A participant identifier must be used at exactly one site.Resolve TMP-004: ae onset before randomisation - 1 record
Adverse event onset must not precede the participant’s first randomisation datetime in any domain.Supply the missing randomisation date and time - 32 records
The primary endpoint cannot be calculated for these participants at all, so they are absent from the analysis.
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
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 | 88.1% | 91.9% | 89.2% | 89.3% | 90.7% | 92.9% |
| outcome_30d | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
| randomisation | 75.0% | 93.8% | 100.0% | 93.8% | 100.0% | 75.0% |
| screening | 82.5% | 95.7% | 91.7% | 86.7% | 86.7% | NA |
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 | 127.00 |
| Not evaluable (no randomisation date) | 32.00 |
| Complete | 39.00 |
| Incomplete (some days unknown) | 56.00 |
| Died within 30 days | 36.00 |
| Total unknown days | 238.00 |
| Mean, all records | 14.18 |
| Mean, complete records only | 2.15 |
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.