DATA CTR & REPOSITORY CORE

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。 数字用户线路板 该协会由罗伯特·亨特博士担任领导，正式成立。还有一名质量控制官员负责审查数据管理中可能存在的违规行为。此外，还有一名助理负责核实提交的相关监管文件是否符合规定。在今年期间，作为调查人员定期会议的一部分，提供了关于数字安全监测机构相关问题的最新情况以及详细说明必须向数字安全监测机构办公室提交的文件的情况报告。该中心的首席调查员随时了解与该委员会有关的所有问题。 在财政年度结束前几个月，向所有调查人员分发一份含有dsmb要求的文件的核对表，目的是在研究年度结束时将所有必要的文件存档。年度评审中评估的文件包括： 1.每个项目的进度报告，以及对项目所作的任何修改。这里详细列出了研究对象的数量，遇到的问题，以及由此产生的出版物和摘要。 2.内部评审委员会当年的批准信(包括对项目的任何修改)。 3.更新同意书，包括所需的修改，如有任何修改。 4.意外事件函件及所需文件 5.所有调查人员的姓名和简历以及研究助理的姓名和资格。 6.对美国国立卫生研究院人类调查课程证书的审查，该课程的网站如下：http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7.已创建并分发给每个站点的保密协议副本。本文件正式规定了所有直接或间接访问患者/客户信息的个人之间的数据保密协议。签字的原件保存在DSMB办公室的档案中。 8.《道德守则》副本，由CCHD调查人员编写并批准。这份文件是在2006年冬天分发的。 存储库 明确目标。为PR-CCHD研究人员提供一个核心设施，便于存储和检索艾滋病毒和丙型肝炎病毒感染者的冷冻淋巴细胞、血浆和血清。此外，该设施提供的服务现在正被来自其他中心和项目的研究人员利用 简要介绍项目说明。来自个别调查人员的条形码冷冻样本储存在温度从0摄氏度到-1400摄氏度的冷冻箱中，并由库存管理软件(Freezerworks F)进行监控。该股改进了现有的艾滋病毒标本库，配备了监测设备，保存库存和质量控制记录。已特别注意遵守HIPAA和IRB的规定。使用人类标本的研究人员被要求寻求(并提供)IRB批准。Maridaliz Rodréguez女士和Myrna Vazquez夫人负责艾滋病毒储存库和实验室信息系统。 本研究的意义。中央储存库为调查人员提供了一个简单可靠的系统，以：a)重复和确认实验室结果；b)根据观察到的趋势增加额外的测试；c)设计新的项目和合作。

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. DSMB The DSMB is formally constituted with Dr. Robert Hunter as its leader. There is also a quality-control officer who reviews possible irregularities in data management. In addition, there is an assistant who verifies that the submitted pertinent regulatory documents are in order. During the course of this year, and as part of the regular meetings of the investigators, updates on the relevant issues concerning the DSMB have been given as well as a status report detailing the documents that must be filed with the DSMB office. The principal investigator of the center is kept informed of all issues relevant to this committee. A checklist with the documents that the DSMB requires is distributed to all investigators several months before the end of the fiscal year with the purpose of having all necessary documentation on file towards the end of the research year. The documents that are evaluated in the yearly review include: 1. A progress report from each project, along with any modifications made to the project. Detailed here is the number of study subjects, problems encountered, and resulting publications and abstracts. 2. An IRB approval letter for the year (including any modifications of the project). 3. Updated consent forms, including required revisions, should there be any. 4. Letters of unexpected events with the required documentation 5. The names and CVs of all investigators and the names and credentials of research assistants. 6. A review of the certificate by the NIH course on Human investigations offered at the following web site: http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7. A copy of the confidentiality agreement that has been created and given to each site. This document formalizes an agreement of data confidentiality by all individuals who directly or indirectly have access to the patient/client information. The signed original is kept on file at the DSMB office. 8. A copy of the code of ethics, which was written and approved by the investigators of the CCHD. This document was distributed in the winter of 2006. REPOSITORY Specific Aim. To provide PR-CCHD researchers with a core facility with easy access to store and retrieve frozen lymphocytes, plasma, and serum from HIV- and HCV-infected individuals. In addition, the services that this facility provides are now being utilized by researchers from other centers and programs Brief Project Description. Bar-coded frozen samples from individual investigators are stored in freezers with temperatures ranging from 0o to -1400C and monitored by inventory management software (Freezerworks F). This unit has improved the existing HIV-specimen repository with monitoring devices that keep inventory and quality control records. Special care has been taken to comply with HIPAA and IRB regulations. Researchers using human specimens are required to seek (and provide proof of) IRB approval. Miss Maridaliz Rodr¿guez and Mrs. Myrna Vazquez are responsible for both the HIV Repository and the Laboratory Information System. Significance of the Study. The centralized repository provides investigators with an easy and reliable system to: a) repeat and confirm laboratory results; b) add additional tests in response to observed trends over time; c) design new projects and collaborations.