Unscheduled Visit: Concomitant Medication Form

Administrative data
Beschrijving

Administrative data

Subject Identifier
Beschrijving

Subject Identifier

Datatype

integer

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

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.

Datatype

boolean

Concomitant Medications
Beschrijving

Concomitant Medications

Drug Name
Beschrijving

Trade name preferred e.g., Aspirin

Datatype

integer

Unit Dose
Beschrijving

Unit Dose

Datatype

integer

Units
Beschrijving

Units

Datatype

text

Maateenheden
  • Units
Units
Frequency
Beschrijving

Frequency

Datatype

text

Route
Beschrijving

Route

Datatype

text

Reason for Medication
Beschrijving

e.g., Headache

Datatype

text

Start Date
Beschrijving

Start Date

Datatype

date

Start Time
Beschrijving

Start Time

Datatype

time

Taken prior to study
Beschrijving

Taken prior to study

Datatype

boolean

Stop Date
Beschrijving

Stop Date

Datatype

date

Stop Time
Beschrijving

Stop Time

Datatype

time

Ongoing medication?
Beschrijving

Ongoing medication?

Datatype

boolean

Similar models

Unscheduled Visit: Concomitant Medication Form

Name
Type
Description | Question | Decode (Coded Value)
Datatype
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