# The Good Laboratory Practice Regulations 1997, Paragraph 21: Content of the study plan


(1) The study plan should contain, but not be limited to, the following information—
(a) Identification of the test and reference substance
(i) a descriptive title,
(ii) a statement which reveals the nature and purpose of the safety study,
(iii) identification of the test substance by code or name (IUPAC, CAS number, etc.),
(iv) the reference substance to be used;
(b) Information concerning the sponsor and the laboratory
(i) name and address of the sponsor,
(ii) name and address of the laboratory,
(iii) name and address of the study director;
(c) Dates
(i) the date of agreement to the study plan by signature of the study director, and when appropriate, of the sponsor and/or the laboratory management,
(ii) the proposed starting and completion dates;
(d) Test methods
reference to OECD test guidelines or other test guidelines 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, substrain, 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,
(v) detailed information on the experimental design, including a description of the chronological procedure of the safety study, all methods, materials and conditions, type and frequency of analysis, measurements, observations and examinations to be performed;
(f) Records
a list of records to be retained.

---
Source: https://www.legislation.gov.uk/uksi/1997/654/schedule/1/paragraph/21 (the official version)
Page: https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.