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pdfPublic reporting burden for this form is estimated to average 10 minutes per response, including the
Form Approved
time for reviewing instructions, searching existing data sources, gathering and maintaining the data
OMB Number 0925‐XXXX
needed, and completing and reviewing the collection of information. An agency may not conduct or
sponsor, and a person is not required to respond to, a collection of information unless it displays a
Exp. Date: XX/XX/XXX
currently valid OMB control number. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden, to: NIH,
Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892‐7974, ATTN: PRA
(0925‐XXXX). Do not return the completed form to this address.
Study ID: __ __ __ __ __ __ __ __ __ __
CEIRS Human Influenza Surveillance Study
Form 2A: Eligibility Checklist
Inclusion Criteria
Symptomatic Influenza Indeterminate
Subjects require YES to all three questions to be eligible for Symptomatic Subject
□ No
1.
Is the subject 18 years old or older
2.
In the past 7 days, has the subject experienced any fever (needs one):
□ No
□ No
a. Documented fever (≥38°C)
b. Report of fever
3.
□ Yes
□ Yes
□ Yes
In the past 7 days, has the subject experienced any of the following symptoms (needs one):
□ No
□ No
□ No
a. Cough
b. Headache
c.
Sore throat
□ Yes
□ Yes
□ Yes
Asymptomatic Influenza Indeterminate
Subjects require YES to Question 1 and NO to all in Question 2 be eligible as Asymptomatic Subject
□ No
□ Yes
1.
Is the subject 18 years old or older
2.
In the past 7 days, has the subject experienced any of the following symptoms:
□ No
□ No
□ No
□ No
□ No
□ No
□ No
□ No
a. Documented fever (≥38°C)
b. Report of fever
c. Cough
d. Headache
e. Sore throat
f. Myalgia
g. Rhinorrhea / nasal congestion
h. Shortness of breath
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
Influenza Positive
Subjects require YES to both questions be eligible as Influenza Positive Subject.
1.
Is the subject 18 years old or older
□ No
□ Yes
2.
Has the subject tested positive for influenza test this visit?
□ No
□ Yes
Page 1 of 2
Form 2A: Eligibility Checklist
Version 2.0
01/05/2015
Study ID: __ __ __ __ __ __ __ __ __ __
Exclusion Criteria
All subjects require NO for each question to be eligible.
□ No
□ No
□ No
□ No
□ No
□ Yes
□ Yes
□ Yes
□ Yes
□ Yes
Is the subject eligible as a Symptomatic Subject?
□ No
□ Yes
Is the subject eligible as an Asymptomatic Subject?
□ No
□ Yes
Is this subject eligible as an Influenza Positive Subject?
□ No
□ Yes
□ No
□ Yes
1.
Unable to write or speak English
2.
Unable to provide informed consent
3.
Unable to provide telephone number for follow-up
4.
Currently incarcerated
5.
Previously enrolled in this study
Eligibility
Consent
Did the subject complete the written consent form?
Page 2 of 2
Form 2A: Eligibility Checklist
Version 2.0
01/05/2015
File Type | application/pdf |
File Title | Data Collection Forms: Johns Hopkins University and Chang Gung University |
Subject | CEIRS Protocol: 14-0076 |
Author | Rebecca Medina |
File Modified | 2015-09-24 |
File Created | 2015-04-08 |