Visit 3: Unsolicited Adverse Events

Administrative data
Beschrijving

Administrative data

Subject Number
Beschrijving

Subject Number

Datatype

integer

Protocol Number
Beschrijving

Protocol Number

Datatype

integer

Date of Visit
Beschrijving

Date of Visit

Datatype

date

Unsolicited Adverse Events
Beschrijving

Unsolicited Adverse Events

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
Beschrijving

Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?

Datatype

text

Similar models

Visit 3: Unsolicited Adverse Events

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Administrative data
Subject Number
Item
Subject Number
integer
Protocol Number
Item
Protocol Number
integer
Date of Visit
Item
Date of Visit
date
Item Group
Unsolicited Adverse Events
Item
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
text
Code List
Has the subject experienced any serious or non-serious adverse events within one month (minimum 30 days) post-vaccination?
CL Item
Information not available (1)
CL Item
No Vaccine administered (2)
CL Item
No (3)
CL Item
Yes, fill in the Non-Serious Adverse Event pages or Serious Adverse Event form (4)