Directive 2004/10/EC of the European Parliament and of the CouncilShow full title

8. Performance of the study U.K.

8.1. Study plan U.K.

1. For each study, a written plan should exist prior to the initiation of the study. The study plan should be approved by dated signature of the study director and verified for GLP compliance by quality assurance personnel as specified in section II2(20)(b). The study plan should also be approved by the test facility management and the sponsor, if required by national regulation or legislation in the country where the study is being performed. U.K.

2.

(a)

Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.

(b)

Deviations from the study plan should be described, explained, acknowledged and dated in a timely fashion by the study director and/or principal investigator(s) and maintained with the study raw data.

3. For short-term studies, a general study plan accompanied by a study specific supplement may be used. U.K.

8.2. Content of the study plan U.K.

The study plan should contain, 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)

A statement which reveals the nature and purpose of the study

(c)

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

(d)

The reference item to be used.

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 by the study director and under the responsibility of the principal investigator(s).

3.

Dates U.K.

(a)

The date of approval of the study plan by signature of the study director. The date of approval of the study plan by signature of the test facility management and sponsor if required by national regulation or legislation in the country where the study is being performed.

(b)

The proposed experimental starting and completion dates.

4.

Test methods U.K.

Reference to the OECD test guideline or other test guideline or method to be used.

5.

Issues (where applicable) U.K.

(a)

The justification for selection of the test system

(b)

Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information

(c)

The method of administration and the reason for its choice

(d)

The dose levels and/or concentration(s), frequency, and duration of administration/application;

(e)

Detailed information on the experimental design, including a description of the chronological procedure of the study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed, and statistical methods to be used (if any).

6.

Records U.K.

A list of records to be retained.

8.3. Conduct of the study U.K.

1. A unique identification should be given to each study. All items concerning this study should carry this identification. Specimens from the study should be identified to confirm their origin. Such identification should enable traceability, as appropriate for the specimen and study. U.K.

2. The study should be conducted in accordance with the study plan. U.K.

3. All data generated during the conduct of the study should be recorded directly, promptly, accurately, and legibly by the individual entering the data. These entries should be signed or initialled and dated. U.K.

4. Any change in the raw data should be made so as not to obscure the previous entry, should indicate the reason for change and should be dated and signed or initialled by the individual making the change. U.K.

5. Data generated as a direct computer input should be identified at the time of data input by the individual(s) responsible for direct data entries. Computerised system design should always provide for the retention of full audit trails to show all changes to the data without obscuring the original data. It should be possible to associate all changes to data with the persons having made those changes, for example, by use of timed and dated (electronic) signatures. Reason for changes should be given. U.K.