Information:
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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 -
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
Vorherige Medikationen
- StudyEvent: Basislinie
- StudyEvent: Woche 1 Visite
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Similar models
Vorherige Medikationen
- StudyEvent: Basislinie
- StudyEvent: Woche 1 Visite
- StudyEvent: Week 2 Visit
- StudyEvent: Patient Diary Event
- StudyEvent: Adverse Event
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Site Number
Item
Klinik Nummer
integer
SITEID (SDTM)
Subject ID
Item
ID des Patienten
text
USUBJID (SDTM)
Visit Date
Item
Besuchsdatum
date
Visit Time
Item
Besuchszeit
time
Item
Hat der Patient Medikamente genommen, die keine Beziehung zum Studium haben
integer
CL Item
Nein (0)
CL Item
Ja (1)
Medication Number
Item
Nummer des Medikaments
integer
Medication Name
Item
Name des Medikaments (Marke oder Generisch)
text
Medication Dose
Item
Totale Dosis per überprüfte Frequenz
text
Medication Dose Units
Item
Einheit
text
CL Item
Eine Dosis (1)
CL Item
Täglich (2)
CL Item
Wöchentlich (3)
CL Item
Monatlich (4)
CL Item
PRN (5)
CL Item
Sonstige (99)
Medication Start Date
Item
Anfangsdatum
date
CL Item
Nein (0)
CL Item
Ja (1)
Medication Stop Date
Item
Datum des Endes
date
Pre-exisitng Illness
Item
Vorherige Krankheit Nummer
integer
Adverse Event
Item
Vorfall Nummer
integer
CL Item
Nein (0)
CL Item
Ja (1)
Prophylaxis Description
Item
Prophylaxis, Beschreibung
text