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。 DSMB正式成立，由Robert Hunter博士担任领导人。Miriam Vel <$zquez女士作为中心的质量控制协调员和Magaly托雷斯女士作为行政助理的重要投入得到了认可。 在这一年中，作为研究者定期会议的一部分，将提供有关DSMB相关问题的更新以及需要向DSMB办公室提交的文件的状态报告。本中心的主要研究者将随时了解与本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。作为年度审查一部分进行审查的文件包括： 1.每个项目的进度报告，沿着可能对项目进行的修改。纳入的主题数量、遇到的问题、出版物和摘要 2.年度IRB批准函和项目修改 3.更新知情同意书，包括所需修订 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.审查由美国国立卫生研究院人类研究课程在以下网站提供的证书。http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp 7. 已创建一份保密文件并分发给每个研究中心。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。签署的文件在DSMB办公室存档。 8. CCHD的研究者编写并批准了道德守则。这是2006年冬天分发的 2007-2008年计划（DSMB） 1.关于研究道德行为的会议计划于今年初冬举行。 2.每年向所有调查人员介绍共同仪器产生的数据 3.继续审查和确保所有项目都有所需文件的监测过程。 E.数据监测 我们已将质量控制专员纳入DSMB成员。她帮助建立报告系统到数据核心的准确度。该活动包括逻辑验证、调查问卷的准确性、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。 数据核心已开始提供所提交数据的摘要，因为它涉及共同文书。这项活动于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。 数据沿着列出了仪器中每个变量的总结以及每个采集中心的变异性总结。就观察到的变异性是否与数据收集/提交过程相关与真实群体多样性进行健康的小组讨论。计划每学期/每年进行一次这项练习，以使研究人员了解所提交数据的全球情况。 预计这一努力将有助于今后文书修改的决定过程，最终改进调查表。 F.安全监测 DSMB负责人审查检查表中列出的所有文件的准确性。他（她）审查提交给中心的所有新研究以及所需文件。计划在这一年进行一次单一地点审查，对受试者进行随机记录审查。

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.