DATA CTR & REPOSITORY CORE

数据点击率

• 批准号: 7961264
• 负责人: ROBERT HUNTER
• 金额: $ 25.95万
• 依托单位: UNIVERSITY OF PUERTO RICO MED SCIENCES
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-24 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7961264
• 关键词: Agreement; Bar Codes; Caring; Client; Clinical Laboratory Information Systems; Codes of Ethics; Collaborations; Computer Retrieval of Information on Scientific Projects Database; Computer software; Confidentiality; Consent Forms; Core Facility; Credentialing; Data; Documentation; Equipment and supply inventories; Event; Freezing; Funding; Grant; HIV; Health Insurance Portability and Accountability Act; Human; Individual; Institution; Investigation; Laboratories; Learning; Letters; Lymphocyte; Modification; Monitor; Names; Patients; Plasma; Principal Investigator; Progress Reports; Publications; Puerto Rico; Quality Control; Records; Regulation; Reporting; Research; Research Ethics Committees; Research Personnel; Resources; Sampling; Services; Site; Source; Specimen; Study Subject; System; Temperature; Testing; Time; United States National Institutes of Health; Update; Writing; abstracting; data management; design; improved; meetings; monitoring device; programs; repository; response; trend; web site

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.

这个子项目是许多研究子项目中的一个 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来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 DSMB DSMB由Robert Hunter博士作为其领导人正式组成。还有一名质量控制干事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法规文件是否齐全。在今年期间，作为研究者定期会议的一部分，已提供了有关DSMB相关问题的更新以及详细说明必须向DSMB办公室提交的文件的状态报告。中心的主要研究者随时了解与该委员会相关的所有问题。 在财政年度结束前几个月，将DSMB要求的文件清单分发给所有研究者，目的是在研究年度结束时将所有必要的文件存档。在年度审查中评估的文件包括： 1.每个项目的进度报告，沿着项目的任何修改。这里详细介绍了研究对象的数量、遇到的问题以及由此产生的出版物和摘要。 2.年度IRB批准函（包括项目的任何修改）。 3.更新的知情同意书，包括必要的修订，如果有任何。 4.非预期事件信函及所需文件 5.所有研究者的姓名和简历以及研究助理的姓名和证书。 6.美国国立卫生研究院人类研究课程提供的证书综述，可访问以下网站：http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7.已创建并提供给每个研究中心的保密协议副本。本文件正式确定了所有直接或间接访问患者/客户信息的个人的数据保密协议。签署的原件在DSMB办公室存档。 8.由CCHD研究者编写并批准的伦理守则副本。该文件于2006年冬季分发。 存储库 具体目标。为PR-CCHD研究人员提供一个核心设施，便于储存和检索HIV和HCV感染者的冷冻淋巴细胞、血浆和血清。此外，该设施所提供的服务目前正被其他中心和项目的研究人员所利用 项目简介。来自各个研究者的条形码冷冻样本储存在温度范围为0 ° C至-1400 ° C的冰柜中，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样本储存库，配备了监测设备，以保持库存和质量控制记录。特别注意遵守HIPAA和IRB法规。使用人体标本的研究人员必须寻求IRB批准（并提供证明）。Maridaliz Rodr <$guez小姐和Myrna Vazquez夫人负责艾滋病毒储存库和实验室信息系统。 研究的意义。集中存储库为研究人员提供了一个简单可靠的系统：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。