Information:
Error:
ID
26206
Description
A sample trial to demonstrate the end-to-end application of the CDISC Standards and transformations from ADL
Keywords
Versions (1)
- 10/11/17 10/11/17 - Philipp Bruland
Copyright Holder
Unknown
Uploaded on
October 11, 2017
DOI
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License
Creative Commons BY-NC-ND 3.0
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Sample Study
Adverse Event Form (ACRO)
- StudyEvent: Baseline Visit
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Similar models
Adverse Event Form (ACRO)
- StudyEvent: Baseline Visit
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Site Number
Item
integer
SITEID (SDTM)
Subject ID
Item
text
USUBJID (SDTM)
Visit Date
Item
date
Visit Time
Item
time
CL Item
(0)
CL Item
(1)
Adverse Event Number
Item
integer
Adverse Event Term
Item
text
Adverse Event Start Date
Item
date
CL Item
(0)
CL Item
(1)
Adverse Event Stop Date
Item
date
AE duration
Item
durationDatetime
CL Item
(0)
CL Item
(1)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(0)
CL Item
(1)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)
CL Item
(1)
CL Item
(2)
CL Item
(3)
CL Item
(4)