Report Statements
The final report contains formal statements from the Study Director and the Quality Assurance personnel.
The OECD Principles of Good Laboratory Practice state that the final report should be signed and dated by the Study Director to indicate acceptance of the responsibility for the validity of the data - and to indicate the extent to which the study complies with the Principles of Good Laboratory Practice.
These are sometimes referred to as an authentication statement and a GLP compliance statement. The signed statement of compliance with the Principles of Good Laboratory Practice will be a legal document in countries where GLP has been incorporated into national law.
Click here for information regarding the second statement in the report
The second statement in the report is provided by Quality Assurance personnel. They are responsible for preparing and signing a Quality Assurance Programme statement to be included in the final report.
This statement should list the types of inspections made and their dates, including the phase inspected, and the dates the inspections were reported to management and the Study Director. It also serves to confirm that the final report reflects the raw data.
