14a 10% Data Accuracy Report

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
End: __ __ / __ __ / __ __ __

Start: __ __ / __ __ / __ __ __

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:

Page 1 of 2

Form 14A: Data accuracy Report

Version 2.0
01/05/2015

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

Subject ID: _________________________________

Criteria
Eligibility

Enrollment

Follow Up
Quality
Control

Page 2 of 2

Number of
Corrections

Incomplete
Y/N

Form 2A: All inclusion criteria met and documented
properly
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
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
Form 12A: Subject Checklist complete

Form 14A: Data accuracy Report

Version 2.0
01/05/2015