Form 32 Attachment 16 Form 14a 10% Data Accuracy Report

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 Surveillance Study Form 14A: 10% Data Accuracy Report

Instructions: This form is to be completed every month during Clinical Study

Site: _ Date: / /

Person Completing this Form:

Enrollment Dates for This Month Start: / / End: / /

Number of Subjects Enrolled this month: _

Number of Subjects Required for QA : (10% or a minimum of 4 subjects, whichever is greater)

For each subject requiring QA, please complete the following table:

Instructions: Complete this chart if QA required and place this form in the corresponding subject’s case report forms binder tab.

Subject ID:

	Criteria	Number of Corrections	Incomplete Y/N
Eligibility	Form 2A: All inclusion criteria met and documented properly
Enrollment	Form 4A: Demographic and exposure Information captured and documented properly
	Form 5A: Current symptoms captured and documented properly
	Form 6A: Medical history captured and documented properly
	Form 7A: (If applicable) Samples collected, processed, and stored properly
Follow Up	Form 8A: Follow Up results documented properly
	Form 9A: ED Chart Review captured and documented properly
	Form 10A: Inpatient Chart Review captured and documented properly
Quality Control	Form 12A: Subject Checklist complete

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Form 14A: Data accuracy Report

Version 2.0 01/05/2015