From: Quality assurance and best research practices for non-regulated veterinary clinical studies
Project Management: Ensure that research objectives, approach, timeline and budget are planned, communicated and understood. | Yes | No |
 1. Project plan (roles and responsibilities, objectives, timeline) |  |  |
 2. Research review plan |  |  |
 3. Research publication plan |  |  |
Personnel Records: Ensure that research records can be traced to competent and appropriate personnel | Yes | No |
 1. Job descriptions, resumes or CVs |  |  |
 2. Signature & initials identification log |  |  |
 3. Training and ongoing competency (procedures, policies, methods, equipment) records |  |  |
Critical Equipment Records: Ensure that research records can be traced to well managed and fully operational equipment | Yes | No |
 1. Equipment inventory log (unique identification) |  |  |
 2. Equipment use, maintenance, verification and calibration records |  |  |
 3. Standard Operating Procedures (SOPs) for use, care and management of equipment |  |  |
 4. Computer systems used to capture, process, generate and report data should be secure, working as expected and fit for their intended purpose. |  |  |
Method/Procedure Records: Ensure that research data can be traced to methods or procedures that are well described, working as expected, and fit for their intended purpose | Yes | No |
 1. SOPs for routine research methods |  |  |
 2. Method validation records |  |  |
 3. On-going quality control records |  |  |
Standard Operating Procedures: Ensure that procedures are performed consistently, revised as needed and maintained as historical records | Yes | No |
 1. Routine procedures: research methods, equipment use, personnel training, data and research management (lab notebooks, research review, reagents and supplies, data (paper and electronic) collection, use and security) |  |  |
 2. Document management (creation, revision, archiving) |  |  |
 3. SOP linkages to associated recording forms |  |  |
Research Records (paper/electronic): Ensure that research data and work (who, what, where, when, how) can be fully reconstructed | Yes | No |
 1. Reagent inventory, reagent characterization, verification and preparation records (receipt, verification, storage, expiration and disposition), supply records |  |  |
 2. Facilities data (temperature, water/air quality, emergency preparedness) if quality critical |  |  |
 3. Unique identification records for research subjects and samples. |  |  |
 4. Sample handling and storage procedures |  |  |
 5. Re-constructable records (accurate, legible, contemporaneous, original, attributable, unchanging, readily retrievable, secure) |  |  |
 6. Error management procedures (detecting, recording, managing errors, outliers and non-conforming data) |  |  |