Concomitant Medication Form

Administrative data
Beskrivning

Administrative data

Subject Identifier
Beskrivning

Subject Identifier

Datatyp

integer

Were any concomitant medications taken by the subject prior to screening and/or during the study?
Beskrivning

If YES, record each medication on a separate line using Trade Names where possible. If the medication is related to a Non-Serious Adverse Event or Serious Adverse Event, details should be expressed using the same terminology.

Datatyp

boolean

Concomitant Medications
Beskrivning

Concomitant Medications

Drug Name
Beskrivning

Trade name preferred e.g., Aspirin

Datatyp

integer

Unit Dose
Beskrivning

Unit Dose

Datatyp

integer

Units
Beskrivning

Units

Datatyp

text

Måttenheter
  • Units
Units
Frequency
Beskrivning

Frequency

Datatyp

text

Route
Beskrivning

Route

Datatyp

text

Reason for Medication
Beskrivning

e.g., Headache

Datatyp

text

Start Date
Beskrivning

Start Date

Datatyp

date

Start Time
Beskrivning

Start Time

Datatyp

time

Taken prior to study
Beskrivning

Taken prior to study

Datatyp

boolean

Stop Date
Beskrivning

Stop Date

Datatyp

date

Stop Time
Beskrivning

Stop Time

Datatyp

time

Ongoing medication?
Beskrivning

Ongoing medication?

Datatyp

boolean

Similar models

Concomitant Medication Form

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Identifier
Item
Subject Identifier
integer
Were any concomitant medications taken by the subject prior to screening and/or during the study?
Item
Were any concomitant medications taken by the subject prior to screening and/or during the study?
boolean
Item Group
Concomitant Medications
Item
Drug Name
integer
Code List
Drug Name
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
Unit Dose
Item
Unit Dose
integer
Units
Item
text
Frequency
Item
Frequency
text
Route
Item
Route
text
Reason for Medication
Item
Reason for Medication
text
Start Date
Item
Start Date
date
Start Time
Item
Start Time
time
Taken prior to study
Item
Taken prior to study
boolean
Stop Date
Item
Stop Date
date
Stop Time
Item
Stop Time
time
Ongoing medication?
Item
Ongoing medication?
boolean