The Good Laboratory Practice Regulations 1999

Content of the Study Plan U.K.

2.—(1) The study plan should contain, but not be limited to, the following information—

(a) Identification of the study, the test item and the reference item

(i) a descriptive title,

(ii) a statement which reveals the nature and purpose of the regulatory study,

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

(iv) the reference item to be used;

(b) Information concerning the sponsor and the test facility

(i) name and address of the sponsor,

(ii) name and address of any test facilities and test sites involved,

(iii) name and address of the study director,

(iv) name and address of any principal investigator, and the phase of the study delegated by the study director to, and under the responsibility of, the principal investigator;

(c) Dates

(i) the date of approval of the study plan by signature of the study director,

(ii) the proposed experimental starting and completion dates;

(d) Test methods

• (d) reference to OECD test guideline or other test guideline or method to be used;

(e) Issues (where applicable)

(i) the justification for selection of the test system,

(ii) characterisation of the test system, such as the species, strain, sub-strain, source of supply, number, body weight range, sex, age, and other pertinent information,

(iii) the method of administration and the reason for its choice,

(iv) the dose levels and/or concentration, frequency, duration of administration or application,

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

(f) Records

• (f) a list of records to be retained.