Information:
Fel:
ID
26206
Beskrivning
A sample trial to demonstrate the end-to-end application of the CDISC Standards and transformations from ADL
Nyckelord
Versioner (1)
- 2017-10-11 2017-10-11 -
Rättsinnehavare
Unknown
Uppladdad den
11 oktober 2017
DOI
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Licens
Creative Commons BY-NC-ND 3.0
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Sample Study
Prior or Concomitant Medications
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Similar models
Prior or Concomitant Medications
- StudyEvent: Baseline
- StudyEvent: Week 1 Visit
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Site Number
Item
Site number
integer
SITEID (SDTM)
Subject ID
Item
Subject ID
text
USUBJID (SDTM)
Visit Date
Item
Visit Date
date
Visit Time
Item
Visit Start Time
time
CL Item
No (0)
CL Item
Yes (1)
Medication Number
Item
Medication No.
integer
Medication Name
Item
Drug Name (Brand or Generic)
text
Medication Dose
Item
Total Dose Per Freqeuncy Checked
text
Medication Dose Units
Item
Unit
text
CL Item
Single Dose (1)
CL Item
Daily (2)
CL Item
Weekly (3)
CL Item
Monthly (4)
CL Item
PRN (5)
CL Item
Other (99)
Medication Start Date
Item
Start Date
date
CL Item
No (0)
CL Item
Yes (1)
Medication Stop Date
Item
Stop Date
date
Pre-exisitng Illness
Item
Pre-existing illness No.
integer
Adverse Event
Item
Adverse Event No.
integer
CL Item
No (0)
CL Item
Yes (1)
Prophylaxis Description
Item
Prophylaxis, Specify
text