# Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance), Division: Reporting of study results

Extent: E+W+S+N.I.

Purpose: to determine whether final reports are prepared in accordance with GLP principles.
When examining a final report, the inspector should check that:
it is signed and dated by the study director to indicate acceptance of responsibility for the validity of the study and confirming that the study was conducted in accordance with GLP principles,
it is signed and dated by other principal scientists, if reports from cooperating disciplines are included,
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.

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Source: https://www.legislation.gov.uk/eudr/2004/9/annex/I/part/B/division/17 (the official version)
Page: https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-17
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.