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Version 1.1

AOAC QUALITATIVE STUDY STATISTICAL REVIEW CHECKLIST

DOCUMENT ID: ______________________________________________________

Approve __ Changes needed, no review __ Changes needed, new review __ Reject __

(Place ‘N’ beside any of the below where a defect is found.)

TITLE:

1. __ Is the analyte stated?

2. __ Is the AOAC method identifier stated?

3. __ Is the type of study described (PTM vs. SLV vs. MLV, etc.)?

ABSTRACT:

4. __ Are required measures of effect reported, along with 95% confidence intervals?

5. __ Are results reported separately for each matrix?

6. __ Are results reported for repeatability and reproducibility with 95% confidence

intervals?

7. __ Is the use of unjustified compositing across matrices or collaborators avoided?

8. __ Are any hypothesis test results reported in proper form and is the observed confidence

interval on measure of effect used to assess any conclusion drawn?

9. __ Is the study identified as matched (paired) or unmatched (unpaired) in methods to

replicates?

10. __ Are the reported results free of improper generalization?

INTRODUCTION:

11. __ Is the current state of the art for the same analyte and matrices properly reviewed?

12. __ Is the previous history of the candidate method reviewed?

METHOD & MATERIALS:

13. __ Are the matrices unambiguously defined sufficiently to allow reproduction of the

study?

14. __ Are the sampling and method of preparation described adequately?

15. __ Is the mixing of the samples homogeneous, and is there validation given for this?

16. __ Is the method of removal of test portions precisely defined so as to indicate preclusion

of possible correlation of results?

17. __ Are outliers excluded solely for physical cause, which has been identified and

supported by objective proof?

18. __ Are the required minimum number of replicates performed?

19. __ Are the required minimum number of collaborators used?

20. __ Is the study identified as matched (paired) or unmatched (unpaired) in methods to

replicates?

21. __ Are the test portion replicates adequately randomized and masked with respect to

preparation and distribution to collaborators?