Unscheduled Visit: Concomitant Medication Form

Administrative data
Beschreibung

Administrative data

Subject Identifier
Beschreibung

Subject Identifier

Datentyp

integer

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

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.

Datentyp

boolean

Concomitant Medications
Beschreibung

Concomitant Medications

Drug Name
Beschreibung

Trade name preferred e.g., Aspirin

Datentyp

integer

Unit Dose
Beschreibung

Unit Dose

Datentyp

integer

Units
Beschreibung

Units

Datentyp

text

Maßeinheiten
  • Units
Units
Frequency
Beschreibung

Frequency

Datentyp

text

Route
Beschreibung

Route

Datentyp

text

Reason for Medication
Beschreibung

e.g., Headache

Datentyp

text

Start Date
Beschreibung

Start Date

Datentyp

date

Start Time
Beschreibung

Start Time

Datentyp

time

Taken prior to study
Beschreibung

Taken prior to study

Datentyp

boolean

Stop Date
Beschreibung

Stop Date

Datentyp

date

Stop Time
Beschreibung

Stop Time

Datentyp

time

Ongoing medication?
Beschreibung

Ongoing medication?

Datentyp

boolean

Ähnliche Modelle

Unscheduled Visit: Concomitant Medication Form

Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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