91ºÚÁÏÍø

A Pilot Study is defined as an animal use protocol (AUP) where the outcome of what is being proposed is generally unknown. This could include the determination of a half-life of a compound; a new procedure/animal model to the University/Lab; or an evaluation of a new procedure against a known procedure. The study may comprise a stand-alone AUP or may be a component of a larger AUP. Pilot Studies are conducted to support the future methodological decisions needed to progress with a full study. A Pilot Study should contain the minimum number of animals to define statistical variability which will enable a power analysis for a more robust study, if warranted. The results of the study should also help define the humane intervention points as well as the experimental endpoints for any future studies.

Additional peer-review for scientific merit is not required if the purpose of the Pilot Study is to develop or evaluate a new method within the context of a peer-reviewed research program. Standalone peer-review is however required if the Pilot Study explores a new research direction that is not covered within the context of an existing peer-reviewed research program.

Pilot Studies are granted a 1-year approval period with a required progress report of the outcomes upon completion. Extensions can be granted with adequate justification. If further work is to be undertaken following the completion of a Pilot Study, a new AUP must be submitted.

Researchers are expected to review any available historical data on side effects of and adverse reactions to experimental treatments and/or surgical procedures prior to the initiation of a study. Available information should be used to anticipate type and duration of supportive care and monitoring required. Researchers should refer to SOP 1.10 (Pilot Studies), and other appropriate SOPs as needed. Very close monitoring will be required to ensure success. Post-procedure or post-administration monitoring of the animal should include observations on appetite, grooming, activity level, weight, hydration status, in addition to other parameters, based on the predicted outcomes, and should be clearly outlined in the AUP.