CDISC Test Study II
This file contains test data for the CDISC Connect-A-Thon event scheduled for the DIA 11th Annual European Workshop on Clinical Data Management.
CDISC-123-456-789
English: Kilogram
French: Kilogram
English: Pound
French: Pound
dilberts/ml
filberts/ml
English: Normal/Abnormal/Not Done?
French: Normal/Abnormal/Not Done?
1
English: The value must be between 1 and 3.
French: The value must be between 1 and 3.
Spanish: The value must be between 1 and 3.
3
The value must be between 1 and 3.
2
English: Is the value really abnormal?
Spanish: ¿Is the value really abnormal?
ABNORM Role
Actions taken re study drug?
None
French: None
Spanish: None
Discontinued permanently
Reduced
Interrupted
None
Medication required
Hospitalization required or prolonged
Other
Resolved, no residual effects
Continuing
Resolved, residual effects
Death
None
Unlikely
Possible
Probable
Mild
Moderate
Severe
Life Threatening
Treatment A
Treatment B
Treatment C
Source verified, not queried
Source verified, queried
Normal
Abnormal
Not Done
Head, Neck and Thyroid
Eyes, Ears, Nose and Throat
Chest
Lungs
Heart
Lymph Nodes
Abdomen
Anorectal
Genitalia
Skin
Musculoskeletal
Neurological
Other
q.d.
b.i.d.
t.i.d.
q.i.d.
q.o.d.
q.h.s.
cont. IV
prn
If not in list, record as Other
IV
IM
PO
SC
PV
PR
Sublingual
Inhaled
Topical
If not in list
United States
Female
Male
Oncology
English
French
Spanish
Shirley Williams
Shirley
Williams
CDISC
John Smith, M.D.
John
Smith
Roswell Park
Jane Doe, M.D.
Jane
Doe
Fred Hutchinson
Signature Meaning
Legal Reason
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