SUBJECT
// CA-0801-101-01
BREED
// Australian Cattle Dog
STATUS
// ACTIVE · RANDOMISED
0x7F3A · MESH 2814v / 5380e · integrity ok
seg[thorax] ▓▓▓▓▓░░ 71% · nodes 14/14
◇ ACQUIRING SUBJECT DATA ◇
Physical Examination
CRF · Day 9
Weight
kg
Temperature
°C
Heart rate
bpm
Query
Q-7AB3
Temperature 39.8 °C outside expected range
Raised by edit check · assigned to CRC
Raised
Awaiting response…
Adverse event coding
VeDDRA
Verbatim:
“itchy red ears, scratching”
matching…
10012312
Otitis externa
10037844
Pruritus
10013774
Dermatitis
Audit Trail
21 CFR Part 11 · immutable
14:02:11
S. Kim
Data Entry
BODY_WEIGHT → 24 kg
14:06:39
Edit check
Query Raised
TEMPERATURE · out of range
15:05:52
A. Reyes
Query Resolved
verified against source
15:19:08
D. Okonkwo
AE Coded
VeDDRA · Otitis externa
Data verified and saved at every step
Investigator (PI)
sees
Full subject record
Sign & verify
Arms masked (blinded)
Coordinator (CRC)
sees
Data entry & queries
Visit scheduling
No unblinding
Monitor (CRA)
sees
Source data verification
Audit trail (read)
Cannot edit data
Sponsor
sees
Aggregate dashboards
Randomisation (unblinded)
No PII by site
Arken
The life of a study
Arken EDC
From the animal in front of you to a locked, auditable record: one continuous chain of custody for veterinary clinical data.
Capture · Verify · Code · Audit
❚❚
Pause