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Paragraph 14 Reporting of study results

Original text. Later amendments are not shown.

(1)

Purpose: To determine whether final reports are prepared in accordance with good laboratory practice principles.

(2)

When a final report is available, the inspector should check that—

  • it is signed and dated by the study director and, where appropriate, by other principal scientists,

  • the study director has signed a statement indicating acceptance of responsibility for the validity of the study and confirming that the study was conducted in accordance with good laboratory practice principles,

  • a quality assurance statement is included in the report and that it is signed and dated,

  • any amendments were made by the responsible personnel,

  • it lists the archive location of all samples, specimens and raw data.