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中文摘要
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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。 该计划的首席研究员、医学校园校长何塞·R·卡洛-伊兹奎尔多博士有责任确保实现计划目标,并为该计划提供适当的机构支持。日常运营的所有职责都委派给项目总监。 RCRII项目有一名主任、一名副主任和一名助理主任。他们努力的百分比加起来提供了100%的全职职位。项目主任胡里奥·E·贝纳贝博士有40%的时间,负责监督整个项目。他主持每周一次的工作人员会议,审查与RCRII日常活动有关的所有问题,并与全体工作人员讨论。PD还参加与RCAC的每月会议,并向他们报告与新研究、已建立的合作的发展以及与RCRII支持的参与计划的联系有关的重要问题。作为退伍军人医院负责研发的副参谋长,Dr。 然而,副主任卡洛斯·卢西亚诺博士(35%)和助理主任玛西娅·克鲁兹博士(25%)允许其中一名主任持续在场,并在项目运作的所有方面协助警察。副项目主任负责与医学学院的教职员工和行政机制进行联络,促进项目目标和具体目标在机构内的实施。 研究临床咨询委员会(RCAC)在RCRII的董事职位上发挥了重要作用。RCAC由两个小组委员会组成,一个内部小组委员会由UPR-MSC的教职员工和研究人员组成,另一个外部小组委员会由我们的外部顾问Brater、Watkins和Palefsky博士组成。RCAC负责批准在RCRII进行的所有议定书,负责选择试点项目的过程,分配RCRII资源,并监督RCRII的运作和 RCRII的政策。它还为P.I.和PDS提供关于科学倡议的建议。 区域合作与合作委员会内部小组委员会每月举行会议,审查所提交的议定书和区域合作与合作委员会第二次会议的总体方向。委员会使用委员会制定和批准的标准格式对每项议定书进行评价,以解决与RCRII的议定书有关的所有问题。每个议定书都由两名作为委员会有投票权的成员的“主要”审查员进行审查,然后由委员会作为一个整体进行审议。要求生物统计学家和RSA提供更多的信息。警务处助理 警务处和助理警务处以无表决权的成员身份出席每次区域反腐败委员会的月会。他们讨论与RCRII的日常活动有关的所有事项,遵守联邦资助计划中进行临床研究的所有规定,审查所有新方案的数据和安全监测计划,并参与所有申请使用RCRII设施的新方案的讨论和评估,以及与其他计划的拟议合作。
英文摘要
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 Principal Investigator of the Program, Dr. Jos¿ R. Carlo-Izquierdo, Chancellor of the Medical Sciences Campus, has the responsibility of ensuring that program goals are met and that appropriate institutional support is provided to the program. All responsibilities of daily operations are delegated to the Program Director. The RCRII Program has a Director, an Associate Director, and an Assistant Director. The combined percentage of their effort provides 100% of a full time position. The Program Director, Dr. Julio E. Benabe, has a 40% time effort and oversees the entire program. He presides a weekly staff meeting where all issues concerning the daily activities of the RCRII are reviewed and discussed with the entire staff. The PD also attends the monthly meeting with the RCAC and reports to them the important issues related to new studies, development of established collaborations, and the links with the participating programs supported by the RCRII. As the Associate Chief of Staff for R&D at the VA Hospital, it is not possible for Dr. Benabe to be physically present in the unit at all times, however, the Associate Director, Dr. Carlos Luciano (35%), and the Assistant Director, Dr. Marcia Cruz (25%), allow for a constant presence of one of the Directors and assist the P.D. in all aspects of the operation of the program. The Associate Program Director serves as a liaison with the faculty and administrative mechanisms in the Medical Sciences Campus, facilitating the implementation of the program's goals and specific aims within the institution. The Research Clinical Advisory Committee (RCAC) has an instrumental role in the directorship of the RCRII. The RCAC is composed of two subcommittees, an internal subcommittee composed of faculty and investigators from the UPR-MSC and an External Subcommittee composed of our external advisors Drs. Brater, Watkins, and Palefsky. The RCAC is responsible for approving all the protocols conducted at the RCRII, for the process of selection of the pilot projects, for the allocation of RCRII resources, and for overseeing the operation and the policies of the RCRII. It also provides advice to the P.I. and the PDs on scientific initiatives. The Internal Subcommittee of the RCAC meets on a monthly basis to review submitted protocols and the general direction of the RCRII. The committee evaluates each protocol using a standard format developed and approved by the committee to address all the relevant issues pertaining protocols at the RCRII. Each protocol is reviewed by two "primary" reviewers who are voting members of the committee and then are considered by the committee as a whole. Additional input from the biostatistician and the RSA is requested. The PD, Associate PD, and Assistant PD attend each of the RCAC monthly meetings as non-voting members. They discuss all matters pertaining to the daily activities at the RCRII, compliance with all the regulations to conduct clinical research in a federally funded program, review data and safety monitoring plans for all new protocols, and participate in the discussion and assessment of all new protocols applying for use of the RCRII facilities as well as in the proposed collaborations with other programs.
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