Screen Visit

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StudyEvent: ODM
1. Screen Visit

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Administrative data

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

Subject Group

Item

Subject Group

text

Subject Group

Code List

Subject Group

CL Item

Part 1 (healthy volunteers; capsaicin challenge) (1)

CL Item

Part 2 (healthy volunteers; capsaicin challenge with treatment) (2)

Demography

Item Group

Demography

Date of Birth

Item

Date of Birth

date

Sex

Item

Sex

text

Sex

Code List

Sex

CL Item

Male (1)

CL Item

Female (2)

child-bearing potential

Item

If Female, record child-bearing potential

text

child-bearing potential

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)

Ethnicity

Item

Ethnicity

text

Ethnicity

Code List

Ethnicity

CL Item

American Hispanic or Latino (1)

CL Item

Not American Hispanic or Latino (2)

Geographic ancestry

Item

Geographic ancestry

text

Geographic ancestry

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)

Vital Signs

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

ECG

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

Method of QTc Calculation

Item

Method of QTc Calculation

integer

Method of QTc Calculation

Code List

Method of QTc Calculation

CL Item

machine (1)

CL Item

manual (2)

Result of the ECG

Item

Result of the ECG

text

Result of the ECG

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)

Eligibility Question

Item Group

Eligibility Question

Item

Did the subject meet all the entry criteria?

text

Eligibility Question

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

Total Symptom Score

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

Visual Analogue Scale

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

Peak Nasal Inspiratory Flow Rate

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

Local Laboratory - Haematology (Lab H)

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

WCB

Item

WCB

text

WCB

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

RBC

Item

RBC

text

RBC

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

Haemoglobin

Item

Haemoglobin

text

Haemoglobin

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

Neutrophils

Item

Neutrophils

text

Neutrophils

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

Lymphocytes

Item

Lymphocytes

text

Lymphocytes

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

Monocytes

Item

Monocytes

text

Monocytes

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

Eosinophils

Item

Eosinophils

text

Eosinophils

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

Basophils

Item

Basophils

text

Basophils

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

Platelets

Item

Platelets

text

Platelets

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

Reticulocyte(Count)

Item

Reticulocyte(Count)

text

Reticulocyte(Count)

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

MCV

Item

MCV

text

MCV

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

MCH

Item

MCH

text

MCH

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

MCHC

Item

MCHC

text

MCHC

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

Local Laboratory - Clinical Chemistry (Lab C)

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

ALT

Item

ALT

text

ALT

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

AST

Item

AST

text

AST

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

Total Bilirubin

Item

Total Bilirubin

text

Total Bilirubin

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

Glucose

Item

Glucose

text

Glucose

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

GGT

Item

GGT

text

GGT

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

Total Protein

Item

Total Protein

text

Total Protein

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

Albumin

Item

Albumin

text

Albumin

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

Potassium

Item

Potassium

text

Potassium

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

Sodium

Item

Sodium

text

Sodium

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

Chloride

Item

Chloride

text

Chloride

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

Creatinine

Item

Creatinine

text

Creatinine

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

Uric acid

Item

Uric acid

text

Uric acid

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

Alkaline Phosphatase

Item

Alkaline Phosphatase

text

Alkaline Phosphatase

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

BUN

Item

BUN

text

BUN

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

Cholesterol

Item

Cholesterol

text

Cholesterol

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

Total CO2

Item

Total CO2

text

Total CO2

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

Triglycerides

Item

Triglycerides

text

Triglycerides

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

Lactate Dehydrogenase

Item

Lactate Dehydrogenase

text

Lactate Dehydrogenase

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

Calcium

Item

Calcium

text

Calcium

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

Plasma ACTH

Item

Plasma ACTH

text

Plasma ACTH

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

Serum Progesterone

Item

Serum Progesterone

text

Serum Progesterone

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

Serum Cortisol

Item

Serum Cortisol

text

Serum Cortisol

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

Serum Testosterone

Item

Serum Testosterone

text

Serum Testosterone

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

SHBG

Item

SHBG

text

SHBG

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

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