1. StudyEvent: ODM
    1. Medication
Administrative Documentation
Beschrijving

Administrative Documentation

Alias
UMLS CUI-1
C1320722
Subject number
Beschrijving

Subject number

Datatype

integer

Alias
UMLS CUI [1]
C2348585
Medication
Beschrijving

Medication

Alias
UMLS CUI-1
C2347852
Have any medications/treatments been administered during the timeframe as specified in the protocol?
Beschrijving

If yes, please complete the table in the following item group.

Datatype

boolean

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

Medication

Alias
UMLS CUI-1
C2347852
Please record the trade name and/or generic name of the medication.
Beschrijving

Trade name | generic name pharmaceutical preparation

Datatype

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
UMLS CUI [2,1]
C0592502
UMLS CUI [2,2]
C0013227
Please record if the medication was administered prophylactically in anticipation of a reaction to the vaccination.
Beschrijving

Pharmaceutical preparations prophylactic treatment vaccine reaction

Datatype

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0199176
UMLS CUI [1,3]
C0042210
UMLS CUI [1,4]
C0443286
Please record the total daily dose
Beschrijving

Pharmaceutical preparations daily dose total

Datatype

text

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C2348070
UMLS CUI [1,3]
C0439810
Please record the route of administration of the medication.
Beschrijving

Please use below-defined codes to indicate medication route.

Datatype

text

Alias
UMLS CUI [1,1]
C0013153
UMLS CUI [1,2]
C0013227
Please record the start date of the administration of the medication.
Beschrijving

Pharmaceutical preparations start date

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
Please record the end date of the administration of the medication.
Beschrijving

If continuing at end of study, please tick the box in the following item.

Datatype

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Please indicate if medication therapy is continuing at end of study.
Beschrijving

Start and end date or tick box if continuing at end of study.

Datatype

boolean

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

Clinical study sponsor comment

Datatype

text

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

Similar models

Medication

  1. StudyEvent: ODM
    1. Medication
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative Documentation
C1320722 (UMLS CUI-1)
Subject number
Item
Subject number
integer
C2348585 (UMLS CUI [1])
Item Group
Medication
C2347852 (UMLS CUI-1)
Pharmaceutical preparations during clinical trial period
Item
Have any medications/treatments been administered during the timeframe as specified in the protocol?
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
Please record the trade name and/or generic name of the medication.
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
Please record if the medication was administered prophylactically in anticipation of a reaction to the 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
Please record the total daily dose
text
C0013227 (UMLS CUI [1,1])
C2348070 (UMLS CUI [1,2])
C0439810 (UMLS CUI [1,3])
Item
Please record the route of administration of the medication.
text
C0013153 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Code List
Please record the route of administration of the medication.
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
Please record the start date of the administration of the medication.
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
Pharmaceutical preparations end date
Item
Please record the end date of the administration of the medication.
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Pharmaceutical preparation continuous
Item
Please indicate if medication therapy is 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])