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How to manage the Microscopic Examination in Urinalysis section?

How to manage the Microscopic Examination in Urinalysis section?

Luglio 19, 2016
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Every blank field in the eCRF is a missing datum. Therefore, if lab reports do not show Pus Cells, RBCs Cells and Casts, there are two possibilities. Option one: the lab report indicates microscopic alterations only if positive. In this case the Investigator should record the result in the patient’s clinical chart and sign it. A 0 (zero) must be entered in the corresponding eCRF field. Option two: the lab report does not investigate microscopic alterations. In this case the Investigator must not record anything in the corresponding eCRF field (missing datum), and it will be considered a protocol deviation.

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