AVMA Animal Health Studies Database

Links to resources concerning the design and conduct of clinical trials and studies, and other resources that would be helpful for investigators:

USDA Website: Veterinary Service Memorandums:

• General Licensing Considerations: Study Practices and Documentation
• General Licensing Considerations: Backpassage Studies
• General Licensing Considerations: Efficacy Studies
• General Licensing Considerations: Compatibility of Components
• General Licensing Considerations: Field Safety Studies

FDA - Center for Veterinary Medicine Website Information:

• CVM GFI #215 Target Animal Safety & Effectiveness Protocol Development & Submission
• VICH GL9 - Good Clinical Practice
• CVM GFI #56 Protocol Development Guideline for Clinical Effectiveness and Target Animal Safety Trials
• CVM GFI #104 Content and Format of Effectiveness and Target Animal Safety Technical Sections and Final Study Reports For Submission
• VICH GL43 - Target Animal Safety for Veterinary Pharmaceutical Products
• CVM GFI #197 Documenting Statistical Analysis Programs and Data Files
• CVM GFI #226 - Target Animal Safety Data Presentation and Statistical Analysis

USDA Website: Biologics Regulations and Guidance:

• Virus-Serum-Toxin Act of 1913, as Amended 1985
• Code of Federal Regulations (9CFR)
• Veterinary Services Memoranda
• Supplemental Assay Methods
• Testing Protocols and Standard Operating Procedures (SOPs)
• Reagent Data Sheets

VICH Website: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products:

• Target Animal Safety - Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence - Annexes
• Target Animal Safety for Veterinary Live and Inactivated Vaccines
• Good Clinical Practices

Miscellaneous resources:

• http://bio-optronics.com/clinical-conductor/resources/
• http://forteresearch.com/resources/
• http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/
• https://gcp.nidatraining.org/
• https://phrp.nihtraining.com/users/login.php?l=3
• https://www.citiprogram.org/index.cfm?pageID=90
• https://www.centerwatch.com/
• http://www.fda.gov/ForPatients/Approvals/default.htm
• http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
• http://www.cancer.net/navigating-cancer-care/how-cancer-treated/clinical-trials/phases-clinical-trials
• https://acrpnet.org/courses/good-clinical-practice-gcp-simulation/
• http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/EducationalMaterials/ucm112925.htm
• https://clinicaltrials.gov/
• http://www.nidcr.nih.gov/research/toolkit/
• https://www.nia.nih.gov/research/dgcg/clinical-research-study-investigators-toolbox
• https://learningcenter.niaid.nih.gov/