7a Enrollment Specimen Collection

Study ID: __ __ __ __ __ __ __ __ __ __
CEIRS Human Influenza Study
Form 7A: Enrollment Specimen Collection
Collecting Institution:
Collecting Country:

□ JHH
□ USA

□ BVMC
□ Taiwan

□ Linkou

□ Taipei

□ Keelung

Which samples have been collected?
Nasopharyngeal Swab:

□ Collected
□ Not indicated (Influenza Positives Only)
□ Patient refused: Reason _________________________
□ Coordinator Unable to Obtain: Reason _________________________
□ Other:_________________________
Blood (Serum) Sample:

□ Collected
□ Patient refused: Reason _________________________
□ Coordinator Unable to Obtain: Reason _________________________
□ Other:_________________________
Nasal Wash:

□ Collected
□ Not indicated
□ Patient refused: Reason _________________________
□ Coordinator Unable to Obtain: Reason _________________________
□ Other:_________________________
For Each Sample collected, please fill out the appropriate information:

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Form 7A: Specimen Collection

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Nasopharyngeal Swab
Collection:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Result:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Rapid Influenza Test Result (Please Check One):

□ Influenza Negative
□ Influenza A Positive
□ Influenza A (H1N1) Positive
□ Influenza B
□ Invalid*
□ Error*
□ No Result*
Was a provider informed of the influenza test result?
Did the subject leave prior to result?

□ No □ Yes □ N/A, no provider assigned
□ No □ Yes

If result positive, participant must be notified of the result.
________________________________________________________
*If initial test is indeterminate, repeat the test and record the result below for the rapid influenza retest:

□ Influenza Negative
□ Influenza A Positive
□ Influenza A (H1N1) Positive
□ Influenza B
□ Invalid
□ Error
□ No Result
Transport to CEIRS laboratory:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________

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Form 7A: Specimen Collection

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Blood (Serum) Sample

Collection:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Placed in refrigerator:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Final sample processing:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________

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Form 7A: Specimen Collection

Version 2.0
01/05/2015

Study ID: __ __ __ __ __ __ __ __ __ __
Nasal Wash
Influenza Test Result:

□ Negative

□ Positive

(Note: Test must be positive in order to collect nasal wash sample)
Influenza Test Type:

□ Cepheid Xpert Flu □ Sofia

□Other;specify:

____________________________
Influenza Test Result:

□ Influenza A
□ Influenza A (H1N1)
□ Other, specify: _____________________

□ Influenza B

Collection:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Placed in refrigerator:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________
Final sample processing:
Date: __ __ / __ __ / __ __ __ __
Time: __ __ : __ __ (hh:mm) (24-hour clock)
Coordinator initials: _________

Subject Notes

Subject Notes:

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Form 7A: Specimen Collection

Version 2.0
01/05/2015