QUALITY CONTROL AND STANDARDIZATION IN DIFFUSE OPTICAL SPECTROSCOPY

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 任何多中心临床试验的成功都取决于数据的一致性收集、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和适当的科学意义。 质量控制和保证不佳可能导致可用数据的丢失，错误的结论，纳税人的钱浪费，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申请的要求，也是试验结果获得医学界认可的必要组成部分。 我们提出了一个质量控制和保证项目，以确保高数据完整性，将支持所有临床试验的目标。 质量控制和保证项目将对本临床试验中采集和报告的所有数据进行标准化、协调和验证。 标准化和验证校准标准和程序。 DOS/I需要分别使用组织模拟体模和反射标准的频域和光谱校准程序。 我们将开发强大的和标准化的校准体模制造，测试和测量程序。 将在该过程中建立Redemption，并由每个临床研究中心验证校准标准品本身的完整性。 我们期望，建立校准标准和程序将最大限度地减少数据丢失，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.