Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (codified version) (Text with EEA relevance) (c. 10)

ANNEX I U.K. THE OECD PRINCIPLES OF GOOD LABORATORY PRACTICE (GLP)

SECTION II U.K. GOOD LABORATORY PRACTICE PRINCIPLES

9. Reporting of study results U.K.

9.1. General U.K.

1. A final report should be prepared for each study. In the case of short-term studies, a standardised final report accompanied by a study specific extension may be prepared. U.K.

2. Reports of principal investigators or scientists involved in the study should be signed and dated by them. U.K.

3. The final report should be signed and dated by the study director to indicate acceptance of responsibility for the validity of the data. The extent of compliance with these principles of good laboratory practice should be indicated. U.K.

4. Corrections and additions to a final report should be in the form of amendments. Amendments should clearly specify the reason for the corrections or additions and should be signed and dated by the study director. U.K.

5. Reformatting of the final report to comply with the submission requirements of a national registration or regulatory authority does not constitute a correction, addition or amendment to the final report. U.K.

9.2. Content of the final report U.K.

The final report should include, but not be limited to, the following information:

1.

Identification of the study, the test item and reference item U.K.

(a)

A descriptive title

(b)

Identification of the test item by code or name (IUPAC, CAS number, biological parameters, etc.)

(c)

Identification of the reference item by name

(d)

Characterisation of the test item including purity, stability and homogeneity.

2.

Information concerning the sponsor and the test facility U.K.

(a)

Name and address of the sponsor

(b)

Name and address of any test facilities and test sites involved

(c)

Name and address of the study director

(d)

Name and address of the principal investigator(s) and the phase(s) of the study delegated, if applicable

(e)

Name and address of scientists having contributed reports to the final report.

3.

Dates U.K.

Experimental starting and completion dates.

4.

Statement U.K.

A quality assurance programme statement listing the types of inspections made and their dates, including the phase(s) inspected, and the dates any inspection results were reported to management and to the study director and principal investigator(s), if applicable. This statement would also serve to confirm that the final report reflects the raw data.

5.

Description of materials and test methods U.K.

(a)

Description of methods and materials used

(b)

Reference to OECD test guideline or other test guideline or method.

6.

Results U.K.

(a)

A summary of results

(b)

All information and data required by the study plan

(c)

A presentation of the results, including calculations and determinations of statistical significance

(d)

An evaluation and discussion of the results and, where appropriate, conclusions.

7.

Storage U.K.

The location(s) where the study plan, samples of test and reference items, specimens, raw data and the final report are to be stored.