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Medication

1 forms  
  1. StudyEvent: ODM
    1. Medication
Administrative Documentation
Description

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Description

Subject number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Study phase
Description

Please indicate the phase for which medication is recorded. A separate form for both double-blind and single-blind phase should be completed. Please consult the study description for relevant medication during the respective phases.

Data type

integer

Alias
UMLS CUI [1,1]
C0205390
UMLS CUI [1,2]
C2603343
Medication
Description

Medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during study period?
Description

If yes, please complete the following item group.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0347984
UMLS CUI [1,3]
C2347804
Medication
Description

Medication

Alias
UMLS CUI-1
C2347852
Trade/generic name
Description

Trade name | generic name pharmaceutical preparation

Data type

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0592502
UMLS CUI [2,2]
C0013227
Prophylactic administration in anticipation of reaction to vaccination?
Description

Pharmaceutical preparations prophylactic treatment vaccine reaction

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C0443286
Total daily dose
Description

Pharmaceutical preparations daily dose total

Data type

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Route of administration
Description

Drug administration route pharmaceutical preparation

Data type

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Start date
Description

Pharmaceutical preparations start date

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date
Description

Please indicate end date or tick the box in the following item if continuing at end of study.

Data type

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Medication continuing at end of study
Description

Tick box if continuing at end of study.

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
For GSK
Description

Clinical study sponsor comment

Data type

text

Alias
UMLS CUI [1,1]
C2347796
UMLS CUI [1,2]
C0947611
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Medication

1 forms
  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item
Study phase
integer
C0205390 (UMLS CUI [1,1])
C2603343 (UMLS CUI [1,2])
Study phase
Code List
Study phase
CL Item
double-blind phase (1)
CL Item
single-blind phase (2)
Item Group
Medication
C2347852 (UMLS CUI-1)
Pharmaceutical preparations during clinical trial period
Item
Have any medications/treatments been administered during study period?
boolean
C0013227 (UMLS CUI [1,1])
C0347984 (UMLS CUI [1,2])
C2347804 (UMLS CUI [1,3])
Item Group
Medication
C2347852 (UMLS CUI-1)
Trade name | generic name pharmaceutical preparation
Item
Trade/generic name
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
C0592502 (UMLS CUI [2,1])
C0013227 (UMLS CUI [2,2])
Pharmaceutical preparations prophylactic treatment vaccine reaction
Item
Prophylactic administration in anticipation of reaction to vaccination?
boolean
C0013227 (UMLS CUI [1,1])
C0199176 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
C0443286 (UMLS CUI [1,4])
Pharmaceutical preparations daily dose total
Item
Total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Route of administration
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Route of administration concomitant vaccination
Code List
Route of administration
CL Item
Intradermal (ID)
CL Item
Inhalation (IH)
CL Item
Intramuscular (IM)
CL Item
Intravenous (IV)
CL Item
Intranasal (NA)
CL Item
Other (OTH)
CL Item
Parenteral (PE)
CL Item
Oral (PO)
CL Item
Subcutaneous (SC)
CL Item
Sublingual (SL)
CL Item
Transdermal (TD)
CL Item
Unknown (UNK)
CL Item
External (EXT)
CL Item
Intraarticular (IR)
CL Item
Intrathecal (IT)
CL Item
Rectal (PR)
CL Item
Topical (TO)
CL Item
Vaginal (VA)
Pharmaceutical preparations start date
Item
Start date
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical preparations end date
Item
End date
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical preparation continuous
Item
Medication continuing at end of study
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
Clinical study sponsor comment
Item
For GSK
text
C2347796 (UMLS CUI [1,1])
C0947611 (UMLS CUI [1,2])
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