From: Quality assurance and best research practices for non-regulated veterinary clinical studies
1. Study Personnel | Â |
2. Background | Â |
3. Objectives | Â |
4. Study Design | Â |
 a. Study Type |  |
 b. Study Overview |  |
 c. Treatment Groups |  |
 d. Randomization Procedures |  |
 e. Blinding Procedures |  |
5. Intervention and Placebo Details | Â |
6. Population Studied | Â |
 a. Institutional Protocol Review |  |
 b. Informed Owner Consent |  |
 c. Animal Identification |  |
 d. Inclusion Criteria |  |
 e. Exclusion Criteria |  |
 f. Removal and Rescue Criteria |  |
7. Assessments | Â |
 a. Veterinary Outcome Measures |  |
 b. Owner Outcome Measures |  |
 c. Patient Biologic Measures |  |
8. Adverse Events | Â |
9. Statistical Analysis | Â |
10. Data Collection, Security and Independent Review | Â |
11. Protocol Deviations and Changes | Â |