Screen Visit

  1. StudyEvent: ODM
    1. Screen Visit
Administrative data
Beskrivning

Administrative data

Subject Initials
Beskrivning

Subject Initials

Datatyp

text

Date of birth
Beskrivning

Date of birth

Datatyp

date

Subject Number
Beskrivning

Subject Number

Datatyp

integer

Date of Visit/Assessment
Beskrivning

Date of Visit/Assessment

Datatyp

date

Subject Group
Beskrivning

Subject Group

Datatyp

text

Demography
Beskrivning

Demography

Date of Birth
Beskrivning

Date of Birth

Datatyp

date

Sex
Beskrivning

Sex

Datatyp

text

If Female, record child-bearing potential
Beskrivning

child-bearing potential

Datatyp

text

Ethnicity
Beskrivning

Ethnicity

Datatyp

text

Geographic ancestry
Beskrivning

Geographic ancestry

Datatyp

text

Vital Signs
Beskrivning

Vital Signs

Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Height
Beskrivning

Height

Datatyp

integer

Måttenheter
  • cm
cm
Weight
Beskrivning

Weight

Datatyp

float

Måttenheter
  • kg
kg
Body Mass Index
Beskrivning

Body Mass Index

Datatyp

float

Måttenheter
  • kg / m2
kg / m2
Blood Pressure - Systolic
Beskrivning

Blood Pressure - Systolic

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Blood Pressure - Diastolic
Beskrivning

Blood Pressure - Diastolic

Datatyp

integer

Måttenheter
  • mmHg
mmHg
Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
ECG
Beskrivning

ECG

Date and Time of ECG
Beskrivning

Date and Time of ECG

Datatyp

datetime

Heart Rate
Beskrivning

Heart Rate

Datatyp

integer

Måttenheter
  • bpm
bpm
PR Interval
Beskrivning

PR Interval

Datatyp

integer

Måttenheter
  • msec
msec
QRS Duration
Beskrivning

QRS Duration

Datatyp

integer

Måttenheter
  • msec
msec
Uncorrected QT Interval
Beskrivning

Uncorrected QT Interval

Datatyp

float

Måttenheter
  • msec
msec
Method of QTc Calculation
Beskrivning

Method of QTc Calculation

Datatyp

integer

Result of the ECG
Beskrivning

Result of the ECG

Datatyp

text

Eligibility Question
Beskrivning

Eligibility Question

Did the subject meet all the entry criteria?
Beskrivning

Eligibility Question

Datatyp

text

Specify violated criteria
Beskrivning

Specify violated criteria

Datatyp

text

Comment
Beskrivning

Comment

Datatyp

text

Total Symptom Score
Beskrivning

Total Symptom Score

Actual date/time
Beskrivning

Actual date/time

Datatyp

datetime

Nasal congestion score
Beskrivning

Nasal congestion score

Datatyp

integer

Rhinorrhoea score
Beskrivning

Rhinorrhoea score

Datatyp

integer

Lacrimation score
Beskrivning

Lacrimation score

Datatyp

integer

Burning/pain score
Beskrivning

Burning/pain score

Datatyp

integer

Total Symptom Score
Beskrivning

Total Symptom Score

Datatyp

text

Visual Analogue Scale
Beskrivning

Visual Analogue Scale

Date/time of assessment
Beskrivning

Date/time of assessment

Datatyp

datetime

Nasal Congestion VAS Score
Beskrivning

Nasal Congestion VAS Score

Datatyp

text

Måttenheter
  • mm
mm
Rhinorrhoea VAS Score
Beskrivning

Rhinorrhoea VAS Score

Datatyp

text

Måttenheter
  • mm
mm
Lacrimation VAS Score
Beskrivning

Lacrimation VAS Score

Datatyp

text

Måttenheter
  • mm
mm
Burning/Pain VAS Score
Beskrivning

Burning/Pain VAS Score

Datatyp

text

Måttenheter
  • mm
mm
Peak Nasal Inspiratory Flow Rate
Beskrivning

Peak Nasal Inspiratory Flow Rate

Date/time of test
Beskrivning

Date/time of test

Datatyp

datetime

PNIF reading 1
Beskrivning

PNIF reading 1

Datatyp

integer

PNIF reading 2
Beskrivning

PNIF reading 2

Datatyp

integer

PNIF reading 3
Beskrivning

PNIF reading 3

Datatyp

integer

Local Laboratory - Haematology (Lab H)
Beskrivning

Local Laboratory - Haematology (Lab H)

Date/time of sample taken
Beskrivning

If any of the lab results fall under the definition of an AE, please record on the medical history

Datatyp

datetime

Has the subject fasted?
Beskrivning

Has the subject fasted?

Datatyp

boolean

WCB
Beskrivning

WCB

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

RBC
Beskrivning

RBC

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Haemoglobin
Beskrivning

Haemoglobin

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Neutrophils
Beskrivning

Neutrophils

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Lymphocytes
Beskrivning

Lymphocytes

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Monocytes
Beskrivning

Monocytes

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Eosinophils
Beskrivning

Eosinophils

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Basophils
Beskrivning

Basophils

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Platelets
Beskrivning

Platelets

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Reticulocyte(Count)
Beskrivning

Reticulocyte(Count)

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

MCV
Beskrivning

MCV

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

MCH
Beskrivning

MCH

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

MCHC
Beskrivning

MCHC

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Local Laboratory - Clinical Chemistry (Lab C)
Beskrivning

Local Laboratory - Clinical Chemistry (Lab C)

Date and Time sample taken
Beskrivning

Date/time sample taken

Datatyp

datetime

Has the subject fasted?
Beskrivning

Has the subject fasted?

Datatyp

boolean

ALT
Beskrivning

ALT

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

AST
Beskrivning

AST

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Total Bilirubin
Beskrivning

Total Bilirubin

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Glucose
Beskrivning

Glucose

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

GGT
Beskrivning

GGT

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Total Protein
Beskrivning

Total Protein

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Albumin
Beskrivning

Albumin

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Potassium
Beskrivning

Potassium

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Sodium
Beskrivning

Sodium

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Chloride
Beskrivning

Chloride

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Creatinine
Beskrivning

Creatinine

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Uric acid
Beskrivning

Uric acid

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Alkaline Phosphatase
Beskrivning

Alkaline Phosphatase

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

BUN
Beskrivning

BUN

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Cholesterol
Beskrivning

Cholesterol

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Total CO2
Beskrivning

Total CO2

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Triglycerides
Beskrivning

Triglycerides

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Lactate Dehydrogenase
Beskrivning

Lactate Dehydrogenase

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Calcium
Beskrivning

Calcium

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Plasma ACTH
Beskrivning

Plasma ACTH

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

boolean

Character result
Beskrivning

Character result

Datatyp

text

Serum Progesterone
Beskrivning

Serum Progesterone

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Serum Cortisol
Beskrivning

Serum Cortisol

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Serum Testosterone
Beskrivning

Serum Testosterone

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

SHBG
Beskrivning

SHBG

Datatyp

text

Numeric result
Beskrivning

Numeric result

Datatyp

integer

Character result
Beskrivning

Character result

Datatyp

text

Similar models

Screen Visit

  1. StudyEvent: ODM
    1. Screen Visit
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
Subject Initials
Item
Subject Initials
text
Date of birth
Item
Date of birth
date
Subject Number
Item
Subject Number
integer
Date of Visit/Assessment
Item
Date of Visit/Assessment
date
Item
Subject Group
text
Code List
Subject Group
CL Item
Part 1 (healthy volunteers; capsaicin challenge) (1)
CL Item
Part 2 (healthy volunteers; capsaicin challenge with treatment) (2)
Item Group
Demography
Date of Birth
Item
Date of Birth
date
Item
Sex
text
Code List
Sex
CL Item
Male (1)
CL Item
Female (2)
Item
If Female, record child-bearing potential
text
Code List
If Female, record child-bearing potential
CL Item
post- menopausal (1)
CL Item
Sterile (of child-bearing age) (2)
CL Item
Potentially able to bear children (3)
Item
Ethnicity
text
Code List
Ethnicity
CL Item
American Hispanic or Latino (1)
CL Item
Not American Hispanic or Latino (2)
Item
Geographic ancestry
text
Code List
Geographic ancestry
CL Item
African Heritage / African American (1)
CL Item
American Indian or Alaskan Native (2)
CL Item
Asian - Central/South Asian Heritage (3)
CL Item
Asian - East Asian Heritage (4)
CL Item
Asian - Japanese Heritage (5)
CL Item
Asian - South East Asian Heritage (6)
CL Item
Native Hawaiian or Other Pacific Islander (7)
CL Item
White - Arabic / North African Heritage (8)
CL Item
White - Caucasian / European Heritage (9)
CL Item
Other (10)
Item Group
Vital Signs
Actual date/time
Item
Actual date/time
datetime
Height
Item
Height
integer
Weight
Item
Weight
float
Body Mass Index
Item
Body Mass Index
float
Blood Pressure - Systolic
Item
Blood Pressure - Systolic
integer
Blood Pressure - Diastolic
Item
Blood Pressure - Diastolic
integer
Heart Rate
Item
Heart Rate
integer
Item Group
ECG
Date and Time of ECG
Item
Date and Time of ECG
datetime
Heart Rate
Item
Heart Rate
integer
PR Interval
Item
PR Interval
integer
QRS Duration
Item
QRS Duration
integer
Uncorrected QT Interval
Item
Uncorrected QT Interval
float
Item
Method of QTc Calculation
integer
Code List
Method of QTc Calculation
CL Item
machine (1)
CL Item
manual (2)
Item
Result of the ECG
text
Code List
Result of the ECG
CL Item
Normal (1)
CL Item
Abnormal - Not clinically significant (2)
CL Item
Abnormal - Clinically significant (3)
CL Item
No result (not available) (4)
Item Group
Eligibility Question
Item
Did the subject meet all the entry criteria?
text
Code List
Did the subject meet all the entry criteria?
CL Item
Yes (1)
CL Item
No (2)
Specify violated criteria
Item
Specify violated criteria
text
Comment
Item
Comment
text
Item Group
Total Symptom Score
Actual date/time
Item
Actual date/time
datetime
Nasal congestion score
Item
Nasal congestion score
integer
Rhinorrhoea score
Item
Rhinorrhoea score
integer
Lacrimation score
Item
Lacrimation score
integer
Burning/pain score
Item
Burning/pain score
integer
Total Symptom Score
Item
Total Symptom Score
text
Item Group
Visual Analogue Scale
Date/time of assessment
Item
Date/time of assessment
datetime
Nasal Congestion VAS Score
Item
Nasal Congestion VAS Score
text
Rhinorrhoea VAS Score
Item
Rhinorrhoea VAS Score
text
Lacrimation VAS Score
Item
Lacrimation VAS Score
text
Burning/Pain VAS Score
Item
Burning/Pain VAS Score
text
Item Group
Peak Nasal Inspiratory Flow Rate
Date/time of test
Item
Date/time of test
datetime
PNIF reading 1
Item
PNIF reading 1
integer
PNIF reading 2
Item
PNIF reading 2
integer
PNIF reading 3
Item
PNIF reading 3
integer
Item Group
Local Laboratory - Haematology (Lab H)
Date/time of sample taken
Item
Date/time of sample taken
datetime
Has the subject fasted?
Item
Has the subject fasted?
boolean
Item
WCB
text
Code List
WCB
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
RBC
text
Code List
RBC
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Haemoglobin
text
Code List
Haemoglobin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Neutrophils
text
Code List
Neutrophils
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Lymphocytes
text
Code List
Lymphocytes
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Monocytes
text
Code List
Monocytes
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Eosinophils
text
Code List
Eosinophils
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Basophils
text
Code List
Basophils
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Platelets
text
Code List
Platelets
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Reticulocyte(Count)
text
Code List
Reticulocyte(Count)
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
MCV
text
Code List
MCV
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
MCH
text
Code List
MCH
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
MCHC
text
Code List
MCHC
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item Group
Local Laboratory - Clinical Chemistry (Lab C)
Date/time sample taken
Item
Date and Time sample taken
datetime
Has the subject fasted?
Item
Has the subject fasted?
boolean
Item
ALT
text
Code List
ALT
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
AST
text
Code List
AST
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Total Bilirubin
text
Code List
Total Bilirubin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Glucose
text
Code List
Glucose
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
GGT
text
Code List
GGT
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Total Protein
text
Code List
Total Protein
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Albumin
text
Code List
Albumin
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Potassium
text
Code List
Potassium
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Sodium
text
Code List
Sodium
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Chloride
text
Code List
Chloride
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Creatinine
text
Code List
Creatinine
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Uric acid
text
Code List
Uric acid
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Alkaline Phosphatase
text
Code List
Alkaline Phosphatase
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
BUN
text
Code List
BUN
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Cholesterol
text
Code List
Cholesterol
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Total CO2
text
Code List
Total CO2
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Triglycerides
text
Code List
Triglycerides
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Lactate Dehydrogenase
text
Code List
Lactate Dehydrogenase
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Calcium
text
Code List
Calcium
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Plasma ACTH
text
Code List
Plasma ACTH
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
boolean
Character result
Item
Character result
text
Item
Serum Progesterone
text
Code List
Serum Progesterone
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Serum Cortisol
text
Code List
Serum Cortisol
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
Serum Testosterone
text
Code List
Serum Testosterone
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text
Item
SHBG
text
Code List
SHBG
CL Item
Numeric result (1)
CL Item
Character result (2)
CL Item
No result (3)
Numeric result
Item
Numeric result
integer
Character result
Item
Character result
text