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Injection Site Reaction

1 forms  
Administrative data
Description

Administrative data

Study Name
Description

Study Name

Data type

text

Site
Description

Site

Data type

text

Subject
Description

Subject

Data type

text

Visit Name
Description

Visit Name

Data type

text

DCI Name/Shortname
Description

DCI Name/Shortname

Data type

text

Status
Description

Status

Data type

text

Doc#
Description

Doc#

Data type

integer

Visit #
Description

Visit #

Data type

float

Injection Site Reaction
Description

Injection Site Reaction

AE/SAE Number
Description

AE/SAE Number

Data type

integer

Date of Injection
Description

Date of Injection

Data type

date

Date of Reaction
Description

Date of Reaction

Data type

date

Size of Skin Reaction
Description

record maximal size

Data type

text

Measurement units
  • mm
mm
Location of Injection
Description

Location of Injection

Data type

text

If Other, specify
Description

If Other, specify

Data type

text

Was the local reaction within 24 hours of dose?
Description

Was the local reaction within 24 hours of dose?

Data type

boolean

Local reaction symptoms
Description

Local reaction symptoms

check all that apply
Description

check all that apply

Data type

text

Redness/Erythema
Description

Redness/Erythema

Data type

text

Itching/Pruritis
Description

Itching/Pruritis

Data type

text

Raised
Description

Raised

Data type

text

Warmth
Description

Warmth

Data type

text

Other symptoms
Description

Other symptoms

Data type

text

If Other symptoms, specify
Description

If Other symptoms, specify

Data type

text

Was treatment given for this local reaction?
Description

Was treatment given for this local reaction?

Data type

text

Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.
Description

Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.

Serum sample obtained?
Description

Serum sample obtained?

Data type

boolean

If YES, please provide Date
Description

If YES, please provide Date

Data type

date

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Similar models

Injection Site Reaction

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
Study Name
Item
Study Name
text
Site
Item
Site
text
Subject
Item
Subject
text
Visit Name
Item
Visit Name
text
DCI Name/Shortname
Item
DCI Name/Shortname
text
Status
Item
Status
text
Doc#
Item
Doc#
integer
Visit #
Item
Visit #
float
Item Group
Injection Site Reaction
AE/SAE Number
Item
AE/SAE Number
integer
Date of Injection
Item
Date of Injection
date
Date of Reaction
Item
Date of Reaction
date
Size of Skin Reaction
Item
Size of Skin Reaction
text
Item
Location of Injection
text
Location of Injection
Code List
Location of Injection
CL Item
Left Abdomen (1)
CL Item
Right Abdomen (2)
CL Item
Other (3)
If Other, specify
Item
If Other, specify
text
Was the local reaction within 24 hours of dose?
Item
Was the local reaction within 24 hours of dose?
boolean
Item Group
Local reaction symptoms
check all that apply
Item
check all that apply
text
Item
Redness/Erythema
text
Redness/Erythema
Code List
Redness/Erythema
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Itching/Pruritis
text
Itching/Pruritis
Code List
Itching/Pruritis
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Raised
text
Raised
Code List
Raised
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Warmth
text
Warmth
Code List
Warmth
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
Item
Other symptoms
text
Other symptoms
Code List
Other symptoms
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
If Other symptoms, specify
Item
If Other symptoms, specify
text
Item
Was treatment given for this local reaction?
text
Was treatment given for this local reaction?
Code List
Was treatment given for this local reaction?
CL Item
No (1)
CL Item
Yes (If Yes, please record all treatments on the concomitant medications/Non-drug Therapies eCRF) (2)
Item Group
Subjects with a severe injection site reaction or a severe systemic allergic reaction must have three 1mL serum samples obtained for immunogenicity testing.
Serum sample obtained?
Item
Serum sample obtained?
boolean
If YES, please provide Date
Item
If YES, please provide Date
date
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