Form 26 Attachment 9 Form 7a Enrollment Speciment Collection

Form Approved

OMB Number 0925-XXXX

Exp. Date: XX/XX/XXX

Public reporting burden for this form is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data 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 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.

CEIRS Human Influenza Study Form 7A: Enrollment Specimen Collection

Collecting Institution: □ JHH □ BVMC □ Linkou □ Taipei □ Keelung Collecting Country: □ USA □ Taiwan

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:

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? □ No □ Yes □ N/A, no provider assigned Did the subject leave prior to result? □ 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:

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:

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) □ Influenza B

• Other, specify:

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