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Quality assurance and best research practices for non-regulated veterinary clinical studies

机译:非管制兽医临床研究的质量保证和最佳研究实践

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Veterinary clinical trials generate data that advance the transfer of knowledge from clinical research to clinical practice in human and veterinary settings. The translational success of non-regulated and regulated veterinary clinical studies is dependent upon the reliability and reproducibility of the data generated. Clinician-scientists that conduct veterinary clinical studies would benefit from a commitment to research quality assurance and best practices throughout all non-regulated and regulated research environments. Good Clinical Practice (GCP) guidance documents from the FDA provides principles and procedures designed to safeguard data integrity, reliability and reproducibility. While these documents maybe excessive for clinical studies not intended for regulatory oversight it is important to remember that research builds on research. Thus, the quality and accuracy of all data and inference generated throughout the research enterprise remains vulnerable to the impact of potentially unreliable data generated by the lowest performing contributors. The purpose of this first of a series of statement papers is to outline and reference specific quality control and quality assurance procedures that should, at least in part, be incorporated into all veterinary clinical studies.
机译:兽医临床试验生成的数据可促进知识在人类和兽医环境中从临床研究到临床实践的转移。不受监管和受监管的兽医临床研究的翻译成功取决于所生成数据的可靠性和可重复性。进行兽医临床研究的临床科学家将受益于在所有不受监管和受监管的研究环境中致力于研究质量保证和最佳实践的承诺。 FDA的《良好临床规范》(GCP)指导文件提供了旨在保护数据完整性,可靠性和可再现性的原则和程序。尽管这些文件对于临床研究而言可能是多余的,但并非旨在进行监管监督,但重要的是要记住研究是建立在研究之上的。因此,整个研究企业中生成的所有数据和推论的质量和准确性仍然容易受到性能最低的贡献者生成的潜在不可靠数据的影响。一系列声明文件中的第一篇的目的是概述和参考具体的质量控制和质量保证程序,这些程序应至少部分地纳入所有兽医临床研究中。

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