Protocol.

§ 792.120 Protocol.

(a) Each study shall have an approved written protocol that clearly indicates the objectives and all methods for the conduct of the study. The protocol shall contain but shall not necessarily be limited to the following information:

(1) A descriptive title and statement of the purpose of the study.

(2) Identification of the test, control, and reference substance by name, chemical abstracts service (CAS) number or code number.

(3) The name and address of the sponsor and the name and address of the testing facility at which the study is being conducted.

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