SANDBOX
Northeast Research Network · all sites & studies
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Network

Network overview

6 sites · 4 studies · updated 2 min ago
Sites
6
Participants
642
Devices
1,310
Open alertsVitals currently out of range, awaiting coordinator review. Clinical — separate from data plumbing.scope: all sites · unit: open alerts
23
Integrity issuesRecords that arrived but can't be trusted — unmapped, EDC-rejected, or mismatched. A subset of open exceptions.scope: network · unit: records
34

Sites

click a site to drill in
SiteStudiesEnrolledCompletenessAlertsEDC sync
Boston314898.4%4in sync
Chicago212197.1%3in sync
Houston213491.2%92 pending
Phoenix16399.0%1in sync
Miami29884.6%6integrity issue
Seattle17896.8%0in sync
Miami and Houston need attention today.
NetworkMiami
Site

Miami site

PI: Dr. A. Reyes · 2 studies active
needs attention
Enrolled
98
Devices
196
Completeness
84.6%
Open alerts
6
EDC sync
integrity issue

Studies at this site

StudyCROEnrolledCompletenessEDC sync
CARD-118ICON5779.2%18 rejected → Medidata
RESP-072Fortrea4192.1%in sync
The red is CARD-118: low completeness plus 18 records rejected by ICON's Medidata EDC.

Participants

sorted by attention needed
5 of 5 participants
ParticipantStudyLast readingDeviceAlertsComplete
0341CARD-11808:15 homeunpairedBP high71%
0355CARD-1183 days agolow battery—62%
0362RESP-07207:40 homeunpaired 6hpulse low88%
0348CARD-11810 min ago homepaired—97%
0370RESP-07220 Jun on-sitepaired—99%
Click a participant to open their monitoring view.
MiamiParticipant 0192
Participant · study ONC-204

Participant 0192

enrolled 42 days · next on-site visit 18 Jul
device connected
on-site at home seamless view · all sources merged
Weightin range
81.4 kg
baseline 80.9 · ±2 kg alert
home · 07:02
Blood pressurehigh
148/94 mmHg
normal <130/80
home · 08:15
Pulsein range
74 bpm
normal 60–100
home · 08:15

Reading history

WhenSourceCollected asVitalValueStatus
Today 08:15homeRemote monitoringBlood pressure148/94high
Today 07:02homeRemote monitoringWeight81.4 kgnormal
28 Jun 10:40on-siteWk 4 visitBlood pressure132/85normal
28 Jun 10:38on-siteWk 4 visitWeight80.9 kgnormal
20 Jun 14:10virtual visitUnscheduledBlood pressure150/96high

How readings are classified

source × how it was collected
SourceRemote monitoringScheduled visitUnscheduled
Home (self)●—●
Virtual visit—●●
On-site—●●
Home nurse—●●
Source = how a reading was captured (self vs. clinician-attended); collected as = where it sits in the schedule. The two are independent — e.g., Home + Unscheduled = a symptom-driven self-reading · Virtual visit + Scheduled visit = the Wk 2 virtual visit · Home + Remote monitoring = the routine daily reading.
Devices

Device fleet & integrity

every state change is logged to the audit trail
Deployed
1,310
Connected now
1,284
Needs attention
23
Integrity issues
3

Deployed devices

5 of 5 devices
DeviceSiteStudyParticipantConnectionLast syncIntegrity
BP cuff — Omron SN-4471BostonONC-2040192paired1 min agoclean
Scale — Withings SN-2288BostonONC-2040192paired2 hrs agoclean
Pulse ox — Masimo SN-9103HoustonCARD-1180177unpaired 6h6 hrs agogap
BP cuff — Omron SN-8841MiamiCARD-118unassignedidle3 days agounmapped
Scale — Withings SN-6620BostonONC-2040203low battery9 hrs agoclean
Assigned devices take their site from the participant; the unassigned SN-8841 shows its site from inventory allocation (Miami stock, not yet bound to a participant).
Device fleetAssign device
Devices

Assign device to participant

bind an unmapped device to a participant to clear the integrity flag

Bind a device to a participant

scan or select

Scan the device QR + the participant’s band, or select above. Study & site are inherited from the participant — no separate entry.

Data operations

Integration mission control

live · last sync 2 min ago
Active studies
7
Devices reporting
1,284 / 1,310
CompletenessReadings received vs. expected. Front of pipe (device → platform) — measures capture, not EDC delivery.scope: active studies · unit: readings
received ÷ expected
98.0%
EDC reconciledRecords the EDC acknowledged as matching. Back of pipe (platform → EDC).scope: all studies · unit: records
acknowledged ÷ transmitted
99.7%
Open exceptionsAll unresolved data-quality records in the triage queue — integrity issues plus out-of-range, gaps, and unit mismatches.scope: network · unit: records
52

Device feed health

SourceDevicesLast dataThroughputStatus
CGM — Dexcom G74121 min agostreaminghealthy
ECG patch — VivaLNK3883 min agostreaminghealthy
Actigraphy — ActiGraph3102.1 hrs agobatch · 6hdegraded
Spirometer — NuvoAir17418 hrs agobatch · daily12 silent

EDC reconciliation — CARD-118

records · this study
Records transmitted28,540
Acknowledged by Medidata28,498
Pending / in flight24
Discrepancies18

Data quality exceptions

records · all studies
unmapped Device SN-8841 → no participant ID Miami · CARD-118
out of range HR 264 bpm · participant 0192 Boston · ONC-204
gap 14h non-wear · participant 0177 Houston · CARD-118
units "beats/min" → normalize to bpm Boston · ONC-204
4 issue types shown · 52 records affected across all studies · 34 are integrity-type (unmapped, rejected, mismatched)

Record lineage — single data point

raw signalDexcom · fw 2.4
normalizedUCUM · UTC
participant-mappedparticipant 0192
validated3 rules passed
in EDCacked 14:03
Participant 0192Report event
Safety · AE / SAE

Adverse event report

One form for both. Classification is set by the seriousness criteria below — check any to escalate to an SAE.
Context · auto-filled
Study
ONC-204
Site
Miami
Reporter
J. Okafor (CRC)
Linked reading
Blood pressure 148/94 mmHg · at home · today 08:15 (above range)

Seriousness criteria

any selection classifies this as an SAE
On submit: recorded to the study record (EDC) and the site log, with a full audit trail.
Safety

Symptom reports

Participant-reported — assess each, then escalate to an AE/SAE or dismiss. The participant reports; you assess.
New
2
Reviewing
1
Escalated to AE · 7d
3
Dismissed · 7d
6
Headache & dizziness
new
0341 · CARD-118 · Miami · reported 20 min ago
“I’ve had a headache and felt dizzy since this morning, a little after my medication.”
Nausea after morning dose
new
0203 · ONC-204 · Boston · reported 2 hrs ago
“Felt nauseous for about an hour after taking the study medication this morning.”
Mild rash on forearm
reviewing · Dr. Reyes
0362 · RESP-072 · Miami · reported today 9:10 AM
“Noticed a small itchy rash on my left forearm yesterday evening.”
Question about dose timing
assessed · not an AE
0388 · CARD-118 · Miami · reported yesterday
“Is it okay to take my reading after breakfast instead of before?”
Filing an AE/SAE opens the report pre-filled from the participant’s message. Dismissed reports stay logged with a reason for the audit trail.
Safety

AE / SAE register

all filed events across the network
Total events
7
Open
3
SAEs
3
SAE due < 24hOpen SAEs still inside the 24-hour expedited-reporting window to the sponsor safety database.scope: network · unit: events
1

Events

newest first
7 of 7 events
EventParticipantStudy / siteTermClassOnsetStatus
AE-0192-040192ONC-204 · BostonHypertensionAE3 Julopen
SAE-0341-010341CARD-118 · MiamiHypertensive crisisSAE3 Julopen · due 6h
SAE-0177-020177CARD-118 · HoustonSyncopeSAE2 Julreported
SAE-0355-010355CARD-118 · MiamiArrhythmia (hospitalized)SAE28 Junreported
AE-0362-020362RESP-072 · MiamiFatigueAE30 Junopen
AE-0203-030203ONC-204 · BostonNauseaAE1 Julclosed
AE-0348-010348CARD-118 · MiamiDizzinessAE29 Junclosed
Class is set by seriousness criteria at filing · SAEs carry a 24-hour reporting clock · click an event to open it.
Configuration

Per-study setup

each study is configured independently — devices, thresholds, EDC and safety routing

Study details

Study code
CARD-118
Sponsor
Cardyn Therapeutics
CRO
ICON
Phase
III
Sites
Miami, Houston
Enrolled
91

Vitals, cadence & alert thresholds

cadence drives completeness · thresholds drive alerts
Weight
Blood pressure
Pulse

EDC target

Connectionconnected
Output formatCDISC / SDTM-ready
Last sync2 min ago

Safety routing

AE destinationEDC (study record)
SAE destinationOracle Argus (sponsor safety)
SAE reporting window24 hours
On SAE filedauto-notify PI + CRO safety

Access & data segregation

who can see this study's data
Northeast Research Networkall roles · full grid
ICON (CRO)study monitor · read-only · CARD-118 only
Cardyn Therapeutics (sponsor)oversight · read-only · CARD-118 only
Other studies' CROsno access
Study-level segregation: ICON sees only CARD-118 across sites — never the ONC-204 or RESP-072 data sitting at the same sites.