Laboratory Rodent Study Protocol Template

1. Study Identification

Project Title Principal Investigator Institution Study Involvement (Departments/Centers) Version/Date

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2. Background and Rationale

Background Rationale/Scientific Justification

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3. Objectives

Primary Objective(s) Secondary Objective(s)

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4. Experimental Design

Study Design Number of Groups and Animals per Group Randomization/Blinding Methods

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5. Animal Information

Species/Strain Sex Male Female Both Age Weight Range Source

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6. Procedures

Description of Procedures Frequency/Duration Analgesia/Anesthesia (if applicable)

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7. Endpoints

Scientific Endpoints Humane Endpoints

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8. Housing and Husbandry

Housing Conditions Diet/Water Environmental Enrichment

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9. Statistical Analysis

Sample Size Justification Statistical Methods

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10. Ethical Considerations

3Rs Considerations (Replacement, Reduction, Refinement) Potential Adverse Effects Monitoring and Reporting

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11. References

Reference List