Division Reporting of study results

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.