QUALITY CONTROL AND STANDARDIZATION IN DIFFUSE OPTICAL SPECTROSCOPY

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 任何多中心临床试验的成功都取决于数据的连贯收集、分析和质量。质量控制和保证是这一成功的关键。质量控制和保证是仪器性能、标准操作程序、数据记录、分析和报告的标准化、验证和合规性检查。良好的质量控制和保证具有良好的科学意义。不好的质量控制和保证可能导致有用数据的损失、不正确的结论、纳税人的金钱浪费，并可能对未来与研究方法相关的资金决策产生负面影响。展望未来，质量控制和保证是任何可能的FDA应用的要求，也是试验结果获得医学界接受的必要组成部分。 我们提出了一个质量控制和保证项目，以确保高度的数据完整性，支持所有临床试验目标。质量控制和保证项目将标准化、协调和验证本次临床试验中获得和报告的所有数据。 标准化和验证校准标准和程序。 DOS/I分别需要使用组织模拟体模和反射率标准的频域和光谱校准程序。我们将制定稳健和标准化的校准模体制造、测试和测量程序。冗余性将被构建到过程中，校准标准本身的完整性将由每个临床站点进行验证。我们预计，建立校准标准和程序将把数据损失降至最低，并提高整体数据质量。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The success of any multi-center clinical trial depends upon the coherent collection, analysis, and quality of the data. Quality control and assurance is a key to this success. Quality control and assurance is the standardization, validation, and compliance checking of Instrumentation performance, standard operating procedures, data logging, analysis, and reporting. Good quality control and assurance makes good and proper scientific sense. Poor quality control and assurance could result in losses of usable data, incorrect conclusions, taxpayer dollar waste, and may negatively impact future funding decisions related to a research methodology. With a further view to the future, quality control and assurance is a requirement for any possible FDA application, and is a necessary component for trial results to gain acceptance by the medical community. We propose a quality control and assurance project to ensure high data integrity that will support all clinical trial aims. The quality control and assurance project will standardize, coordinate and validate all data acquired and reported in this clinical trial. Standardize and validate calibration standards and procedures. DOS/I requires both frequency domain and spectral calibration procedures using tissue simulating phantoms and reflectance standards, respectively. We will develop robust and standardized calibration phantom fabrication, testing, and measurement procedures. Redundancy will be built into the process, and the integrity of the calibration standards themselves will be validated by each clinical site. We expect that the establishment of calibration standards and procedures will minimize data loss and improve overall data quality.