Engelsk

Diary card

1 Formulär  
  1. StudyEvent: ODM
    1. Diary card
Administrative data
Beskrivning

Administrative data

Alias
UMLS CUI-1
C1320722
Subject Number
Beskrivning

Subject Number

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Dose type
Beskrivning

Dose type

Datatyp

integer

Alias
UMLS CUI [1,1]
C3174092
UMLS CUI [1,2]
C0332307
Workbook Number
Beskrivning

6/10/14 weeks schedule for WB1 2/4/6 months schedule for WB 2

Datatyp

integer

Alias
UMLS CUI [1]
C2986015
Please do not forget to bring back the diary card on:
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C3890583
UMLS CUI [1,2]
C0332156
UMLS CUI [1,3]
C0011008
In case of hospitalization, please inform
Beskrivning

Contact person, Name

Datatyp

text

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1547383
Contact person, Telephone number
Beskrivning

Contact person, Telephone number

Datatyp

integer

Alias
UMLS CUI [1,1]
C0337611
UMLS CUI [1,2]
C1515258
Local symptoms (at injection sites)
Beskrivning

Local symptoms (at injection sites)

Alias
UMLS CUI-1
C1457887
UMLS CUI-2
C0205276
Vaccine
Beskrivning

for investigator only: Could you please check the appropriate box (side / site) for assessment. IPV Vaccine: Fill in only for Workbook 2.

Datatyp

integer

Alias
UMLS CUI [1]
C0042210
Vaccine administration, Side
Beskrivning

for investigator only: Could you please check the appropriate box (side / site) for assessment.

Datatyp

text

Alias
UMLS CUI [1,1]
C0441987
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Vaccine administration, Site
Beskrivning

for investigator only: Could you please check the appropriate box (side / site) for assessment. Upper and Lower thigh only options for DTPw-HBV/Hib Vaccine and IPC Vaccine.

Datatyp

integer

Alias
UMLS CUI [1,1]
C1515974
UMLS CUI [1,2]
C0013153
UMLS CUI [1,3]
C0042210
Local symptoms
Beskrivning

Local symptoms

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C2700396
Day after Vaccination
Beskrivning

For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0332282
UMLS CUI [1,5]
C0042196
Size of local symptom
Beskrivning

Please measure the greatest diameter (in mm). Fulfill for Redness and swelling.

Datatyp

integer

Måttenheter
  • mm
Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0456389
mm
Intensity of Pain
Beskrivning

Definition: 0: Absent 1: Minor reaction to touch 2: Cries/protests on touch 3: Cries when limb is moved / spontaneously painful

Datatyp

integer

Alias
UMLS CUI [1,1]
C0518690
UMLS CUI [1,2]
C0030193
Ongoing after Day 3?
Beskrivning

Local symptom ongoing

Datatyp

text

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C0549178
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended Visit
Beskrivning

Medically attended Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Other local symptoms
Beskrivning

Other local symptoms

Alias
UMLS CUI-1
C0205394
UMLS CUI-2
C1457887
UMLS CUI-3
C0205276
Other local symptoms, Description - please specify side(s) and site(s)
Beskrivning

Other local symptoms, description

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C1457887
UMLS CUI [2,3]
C0205276
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C1457887
UMLS CUI [3,3]
C0205276
Other local symptoms, Intensity
Beskrivning

Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0518690
Start date of other local symptom
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
End date of other local symptom
Beskrivning

day month year. or check box below, if continuing.

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0205394
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0205276
Check if other local symptom continuing
Beskrivning

Other local symptom ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0205276
UMLS CUI [1,3]
C1457887
UMLS CUI [1,4]
C0549178
Medically attended Visit
Beskrivning

Medically attended Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
General Symptoms
Beskrivning

General Symptoms

Alias
UMLS CUI-1
C0159028
General symptom
Beskrivning

General symptom

Datatyp

integer

Alias
UMLS CUI [1]
C0159028
Day after Vaccination
Beskrivning

For Day 1-3: note in the evening. Please give information for each symptom and day mentioned.

Datatyp

integer

Alias
UMLS CUI [1,1]
C0439228
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0042196
If "Temperature", please note the route of measurement.
Beskrivning

Body temperature, route of measurement

Datatyp

integer

Alias
UMLS CUI [1,1]
C0886414
UMLS CUI [1,2]
C0449444
Body temperature
Beskrivning

Please record the temperature every day. If temperature has been taken more than once a day, please report the highest value for the day.

Datatyp

float

Måttenheter
  • °C
Alias
UMLS CUI [1]
C0005903
°C
Intensity of symptom
Beskrivning

Definition: Irritability / fussiness: 0: Behavior as usual 1: Crying more than usual / no effect on normal activity 2: Crying more than usual / interferes with normal activity 3: Crying that cannot be comforted / prevents normal activity Drowsiness: 0:Behavior as usual 1:Drowsiness easily tolerated 2:Drowsiness that interferes with normal activity 3:Drowsiness that prevents normal activity Loss of appetite: 0: Appetite as usual 1: Eating less than usual / no effect on normal activity 2: Eating less than usual / interferes with normal activity 3: Not eating at all

Datatyp

integer

Alias
UMLS CUI [1]
C0518690
Ongoing after Day 3?
Beskrivning

General symptom ongoing

Datatyp

text

Alias
UMLS CUI [1,1]
C0159028
UMLS CUI [1,2]
C0549178
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C1457887
Medically attended Visit
Beskrivning

Medically attended Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Other general symptoms
Beskrivning

Other general symptoms

Alias
UMLS CUI-1
C0029625
Other local symptoms, Description - please specify side(s) and site(s)
Beskrivning

Other local symptoms, description

Datatyp

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2,1]
C0441987
UMLS CUI [2,2]
C0678257
UMLS CUI [3,1]
C1515974
UMLS CUI [3,2]
C0678257
Other local symptoms, Intensity
Beskrivning

Definition: Mild: An adverse event which is easily tolerated by the subject, causing minimal discomfort and not interfering with everyday activities. Moderate: An adverse event which is sufficiently discomforting to interfere with normal everyday activities. Severe: An adverse event which prevents normal, everyday activities. (In a young child, such an adverse event would, for example, prevent attendance at school/kindergarten/a day-care center and would cause the parents/guardians to seek medical advice).

Datatyp

integer

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1457887
UMLS CUI [1,3]
C0205276
UMLS CUI [2]
C0518690
Start date of general symptom
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C0159028
End date of general symptom
Beskrivning

day month year. or check box below, if continuing.

Datatyp

date

Alias
UMLS CUI [1,1]
C0806020
UMLS CUI [1,2]
C0159028
Check if other general symptom continuing
Beskrivning

Other general symptom ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C0159028
UMLS CUI [1,3]
C0549178
Medically attended Visit
Beskrivning

Medically attended Visit

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C1386497
UMLS CUI [1,3]
C1518404
Medication
Beskrivning

Medication

Alias
UMLS CUI-1
C0013227
Trade / Generic Name of medication
Beskrivning

Trade / Generic Name of medication

Datatyp

text

Alias
UMLS CUI [1,1]
C2360065
UMLS CUI [1,2]
C0013227
Reason for medication
Beskrivning

Indication of medication

Datatyp

text

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0013227
Total daily dose
Beskrivning

Total daily dose

Datatyp

text

Alias
UMLS CUI [1]
C2826638
Start date of medication
Beskrivning

day month year

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0808070
End date of medication
Beskrivning

day month year. or check box below, if continuing.

Datatyp

date

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0806020
Check if medication continuing
Beskrivning

Medication ongoing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0549178
Tillbaka till toppen

Similar models

Diary card

1 Formulär
  1. StudyEvent: ODM
    1. Diary card
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
text
C2348585 (UMLS CUI [1])
Item
Dose type
integer
C3174092 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Dose type
Code List
Dose type
CL Item
Dose 1 (1)
CL Item
Dose 2 (2)
CL Item
Dose 3 (3)
Item
Workbook Number
integer
C2986015 (UMLS CUI [1])
Workbook Number
Code List
Workbook Number
CL Item
WB 1 (1)
CL Item
WB 2 (2)
Date of diary card return
Item
Please do not forget to bring back the diary card on:
date
C3890583 (UMLS CUI [1,1])
C0332156 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Contact person, Name
Item
In case of hospitalization, please inform
text
C0337611 (UMLS CUI [1,1])
C1547383 (UMLS CUI [1,2])
Contact person, Telephone number
Item
Contact person, Telephone number
integer
C0337611 (UMLS CUI [1,1])
C1515258 (UMLS CUI [1,2])
Item Group
Local symptoms (at injection sites)
C1457887 (UMLS CUI-1)
C0205276 (UMLS CUI-2)
Item
Vaccine
integer
C0042210 (UMLS CUI [1])
Vaccine
Code List
Vaccine
CL Item
10Pn-PD-DiT or Prevenar Vaccine (1)
CL Item
DTPw-HBV/Hib Vaccine (2)
CL Item
IPV Vaccine (3)
Item
Vaccine administration, Side
text
C0441987 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine
Code List
Vaccine administration, Side
CL Item
Left (L)
CL Item
Right (R)
Item
Vaccine administration, Site
integer
C1515974 (UMLS CUI [1,1])
C0013153 (UMLS CUI [1,2])
C0042210 (UMLS CUI [1,3])
Vaccine
Code List
Vaccine administration, Site
CL Item
Arm (1)
CL Item
Thigh (2)
CL Item
Upper thigh (3)
CL Item
Lower thigh (4)
CL Item
Buttock (5)
Item
Local symptoms
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C2700396 (UMLS CUI [1,3])
Local symptoms
Code List
Local symptoms
CL Item
Redness (RE)
CL Item
Swelling (SW)
CL Item
Pain (P)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0332282 (UMLS CUI [1,4])
C0042196 (UMLS CUI [1,5])
Day after Vaccination
Code List
Day after Vaccination
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2  (3)
CL Item
Day 3  (4)
Size of local symptom
Item
Size of local symptom
integer
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Item
Intensity of Pain
integer
C0518690 (UMLS CUI [1,1])
C0030193 (UMLS CUI [1,2])
Intensity of Pain
Code List
Intensity of Pain
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Ongoing after Day 3?
text
C1457887 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Local symptom ongoing
Code List
Ongoing after Day 3?
CL Item
No (N)
CL Item
Yes (Y)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Other local symptoms
C0205394 (UMLS CUI-1)
C1457887 (UMLS CUI-2)
C0205276 (UMLS CUI-3)
Other local symptoms, description
Item
Other local symptoms, Description - please specify side(s) and site(s)
text
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0441987 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
C0205276 (UMLS CUI [2,3])
C1515974 (UMLS CUI [3,1])
C1457887 (UMLS CUI [3,2])
C0205276 (UMLS CUI [3,3])
Item
Other local symptoms, Intensity
integer
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2])
Other local symptoms, Intensity
Code List
Other local symptoms, Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date of other local symptom
Item
Start date of other local symptom
date
C0808070 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
End date of other local symptom
Item
End date of other local symptom
date
C0806020 (UMLS CUI [1,1])
C0205394 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0205276 (UMLS CUI [1,4])
Other local symptom ongoing
Item
Check if other local symptom continuing
boolean
C0205394 (UMLS CUI [1,1])
C0205276 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
C0549178 (UMLS CUI [1,4])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
General Symptoms
C0159028 (UMLS CUI-1)
Item
General symptom
integer
C0159028 (UMLS CUI [1])
General symptom
Code List
General symptom
CL Item
Temperature (1)
CL Item
Irritability/Fussiness (2)
CL Item
Drowsiness (3)
CL Item
Loss of appetite (4)
Item
Day after Vaccination
integer
C0439228 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0042196 (UMLS CUI [1,4])
Day after Vaccination
Code List
Day after Vaccination
CL Item
Day 0 (1)
CL Item
Day 1 (2)
CL Item
Day 2  (3)
CL Item
Day 3  (4)
Item
If "Temperature", please note the route of measurement.
integer
C0886414 (UMLS CUI [1,1])
C0449444 (UMLS CUI [1,2])
Body temperature, route of measurement
Code List
If "Temperature", please note the route of measurement.
CL Item
Axillary (1)
CL Item
Oral (2)
CL Item
Tymp (oral setting) (3)
CL Item
Tymp (rectal setting) (4)
CL Item
Rectal (5)
Body temperature
Item
Body temperature
float
C0005903 (UMLS CUI [1])
Item
Intensity of symptom
integer
C0518690 (UMLS CUI [1])
Intensity of symptom
Code List
Intensity of symptom
CL Item
0 (0)
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
Item
Ongoing after Day 3?
text
C0159028 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
General symptom ongoing
Code List
Ongoing after Day 3?
CL Item
Yes (Y)
CL Item
No (N)
Date of last Day of Symptoms
Item
If symptom is ongoing after Day 3, please specify the date of the last day of symptom
date
C0011008 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C1457887 (UMLS CUI [1,3])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Other general symptoms
C0029625 (UMLS CUI-1)
Other local symptoms, description
Item
Other local symptoms, Description - please specify side(s) and site(s)
text
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0441987 (UMLS CUI [2,1])
C0678257 (UMLS CUI [2,2])
C1515974 (UMLS CUI [3,1])
C0678257 (UMLS CUI [3,2])
Item
Other local symptoms, Intensity
integer
C0205394 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
C0518690 (UMLS CUI [2])
Other local symptoms, Intensity
Code List
Other local symptoms, Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Start date of general symptom
Item
Start date of general symptom
date
C0808070 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
End date of general symptom
Item
End date of general symptom
date
C0806020 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
Other general symptom ongoing
Item
Check if other general symptom continuing
boolean
C0205394 (UMLS CUI [1,1])
C0159028 (UMLS CUI [1,2])
C0549178 (UMLS CUI [1,3])
Item
Medically attended Visit
text
C0545082 (UMLS CUI [1,1])
C1386497 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Medically attended Visit
Code List
Medically attended Visit
CL Item
Yes  (Y)
CL Item
No (N)
Item Group
Medication
C0013227 (UMLS CUI-1)
Trade / Generic Name of medication
Item
Trade / Generic Name of medication
text
C2360065 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Indication of medication
Item
Reason for medication
text
C3146298 (UMLS CUI [1,1])
C0013227 (UMLS CUI [1,2])
Total daily dose
Item
Total daily dose
text
C2826638 (UMLS CUI [1])
Start date of medication
Item
Start date of medication
date
C0013227 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
End date of medication
Item
End date of medication
date
C0013227 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
Medication ongoing
Item
Check if medication continuing
boolean
C0013227 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
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