Protocol
Written and approved protocols must exist for each study,
and they must indicate the purpose of the study and methods to be adopted in
conducting the study. The following information must form a part of the
protocol:
• Title and purpose statement for the study.
• Test and control articles identified by name, code number,
or chemical abstract number.
• Study sponsor name, and testing facility name and address.
• Test system being used – number, sex, age, body weight
range, species, strain, substrain, and supplier details.
• Procedure to identify test system.
• Experimental design description, methods used for bias
control.
• Description of items to be used in the study – diet of
animals, solvents or emulsifiers, and limit values for contaminants likely to
be found in these that may interfere with the study.
• Dosage levels (in mg/kg body weight) of control and test
articles; the frequency and method of administration.
• Tests, measurements, analyses to be performed and their
frequency.
• Information regarding the statistical methods that will be
used in the study.
• Date when study protocol was approved by the sponsor, and
signature with a date by the study director.
• Any changes/revisions in an approved protocol must be
documented along with the reason; it must be signed and dated by the study
director and this document must be kept along with the protocol.
Conduct of the Study
The non-clinical laboratory study must be conducted
according to the protocol. All specimens must be labeled with details of the study,
test system, nature, and date of collection. If a specimen is to be examined
histopathologically by a pathologist, the gross findings from post-mortem
examination must be also available.
Data generated during a study (except
automatically collected data) must be recorded at once, directly, and in
legible ink. The dates and initials of the person making the entry should be
affixed. If any change is to be made, it shall be done in a manner to not
deface the original entry. The reason for the change must be documented, dated,
and signed. In the case of automated data collection systems, the person
responsible for data input must be identified. Any changes in data must follow
the same procedure as for other means of data collection.