PR COMPREHENSIVE CTR FOR HIV DISPARITIES: UCC: 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。 由罗伯特·亨特博士担任领导的dsmb正式成立。米里亚姆·韦尔兹克斯夫人担任中心的质量控制协调员，马加利·托雷斯夫人担任行政助理，她的重要投入得到了肯定。在这一年中，作为调查人员定期会议的一部分，提供了有关数字安全监测机构相关问题的最新情况，以及需要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。作为年度审查的一部分进行审查的文件包括： 1.每个项目的进度报告，以及可能对项目进行的修改。收录的主题数量、遇到的问题、出版物和摘要 2.本年度内部评审委员会批准书及项目修改批准书 3.更新同意书，包括所需修订 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.以下网址提供的国立卫生研究院人类调查课程对证书的审查。Http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7.创建了一份保密文件，并将其分发给每个网站。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。签署的文件保存在dsmb办公室的档案中。 8.制定了一项道德守则，并由CCHD的调查人员批准。这是在2006年冬天发布的。 2007-2008年度计划(数字及广播局) 1.关于研究道德行为的会议计划在今年初冬举行。 2.每年向所有调查员提交共同文书产生的数据 3.继续开展监测进程，审查并确保提供所有项目所需的文件。 E.数据监控 我们已经将质量控制官员纳入了dsmb成员。她帮助确定报告系统对数据核心的准确度。这项活动包括逻辑验证、问卷的准确性、工具的完整程度以及交叉检查可能发生的不良事件的准确性。 数据核心已开始提出所提交数据的摘要，因为它指的是共同文书。这项活动从2006年6月开始，包括介绍每个地点和每个项目提交的与共同文书有关的数据摘要。这些数据提供了仪器中每个变量的摘要，以及每个采集点的变异性摘要。产生了关于观察到的变异性是否与数据收集/提交过程与真正的种群多样性有关的健康的小组讨论。计划每学期/每年进行这项工作，以使调查人员随时了解所提交数据的全球情况。预计这一努力将有助于今后对工具进行修改的决策过程，最终产生一份改进的调查表。 F.安全监测 Dsmb的领导审阅清单中列出的所有文件以确保其准确性。他(她)审查所有提交给中心的新研究，并提供所需的文件。计划在本年度进行一次单一地点审查，对主题进行随机记录审查。

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 DSMB is formally constituted with Dr. Robert Hunter as leader. The important input of Mrs. Miriam Vel¿zquez who functions as the quality control coordinator of the center and Mrs. Magaly Torres as the administrative assistant is acknowledged. During the year and as part of the regular meetings of the investigators updates on the relevant issues concerning the DSMB are given as well as a status report of the documents that are required to be filed with the DSMB office. The principal investigator of the center is kept informed on 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 reviewed as part of the yearly review include: 1. Progress report of each project along with possible modifications made to the project. The number of subjects included, problems encountered, publications and abstracts 2. IRB approval letter for the year and for modifications of the project 3. Updated consent form including revisions required 4. Letters of unexpected events with the required documentation 5. The name and CV of all investigators, and the name and credentials of research assistants. 6. 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 confidentiality document 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 document is kept on file at the DSMB office. 8. A code of ethics was written and approved by the investigators of the CCHD. This was distributed in the winter of 2006 Plans for 2007-2008 (DSMB) 1. Conferences on the ethical conduct of research are being planned for early winter of this year. 2. Annual presentation of the data generated by the common instrument to all investigators 3. Continue the monitoring process of reviewing and ensuring that the required documentation is present for all projects. E. Data Monitoring We have included the quality control officer as a member of the DSMB. She helps in the process of establishing the degree of accuracy of the reporting systems to the data core. This activity includes logical verification, accuracy of the questionnaires, degree of completeness of the instruments, and cross check the accuracy of the adverse events which may occurs. The data core has started to present summaries of the data submitted as it refers to the common instrument. This activity started on June of 2006 and includes presentation of a summary of data submitted per site and per project as it related to the common instrument. The data presents a summary of each variable in the instrument along with a summary of the variability per site of collection. Healthy group discussions regarding whether the observed variability is related to the process of data collection/submission vs. true population diversity is generated. It is planned that this exercise will be conducted every semester/year to keep the investigators in touch the global picture of the data submitted. It is anticipated that this effort will help in the decision process of instrument modification in the future ultimately resulting in an improved questionnaire. F. Safety Monitoring The leader of the DSMB reviews all the documents outlined in the checklist for accuracy. He (she) reviews all new studies submitted to the center with the required documentation. A single site review for a random record review of subjects is planned for the year.