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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)
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Amendments to the study plan should be justified and approved by dated signature of the study director and maintained with the study plan.
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.
The study plan should contain, but not be limited to the following information:
A descriptive title
A statement which reveals the nature and purpose of the study
Identification of the test item by code or name (IUPAC; CAS number, biological parameters, etc.)
The reference item to be used.
Name and address of the sponsor
Name and address of any test facilities and test sites involved
Name and address of the study director
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).
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.
The proposed experimental starting and completion dates.
Reference to the OECD test guideline or other test guideline or method to be used.
The justification for selection of the test system
Characterisation of the test system, such as the species, strain, substrain, source of supply, number, body weight range, sex, age and other pertinent information
The method of administration and the reason for its choice
The dose levels and/or concentration(s), frequency, and duration of administration/application;
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).
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