ADMINISTRATIVE BUDGET

行政预算

• 批准号: 7959666
• 负责人: Jose R. Carlo
• 金额: $ 28.94万
• 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: 2009-07-01 至 2010-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7959666
• 关键词: Address; Advisory Committees; Budgets; Clinical; Clinical Research; Collaborations; Committee Members; Computer Retrieval of Information on Scientific Projects Database; Data; Development; Ensure; Faculty; Funding; Goals; Grant; Hospitals; Institution; Link; Medical; Monitor; Operative Surgical Procedures; Pilot Projects; Policies; Positioning Attribute; Principal Investigator; Process; Program Reviews; Protocols documentation; Regulation; Reporting; Research; Research Personnel; Resources; Role; Safety; Science; Source; Time; United States National Institutes of Health; Voting; base; meetings; member; programs; research and development

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.

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。 该项目的主要研究员，博士何塞·R。医学科学校园校长卡洛-伊兹基耶多（Carlo-Izquierdo）有责任确保实现计划目标，并为计划提供适当的机构支持。日常运作的所有职责均委托给项目总监。 RCRII计划有一名主任，一名副主任和一名助理主任。他们的努力的综合百分比提供了100%的全职职位。项目负责人Julio E. Benabe有40%的时间工作，并监督整个项目。他主持每周一次的工作人员会议，与全体工作人员一起审查和讨论与第二研究中心日常活动有关的所有问题。政策司还参加与驻地协调员评估中心的月度会议，并向他们报告与新研究、已建立的合作关系的发展以及与RCRII支持的参与计划的联系有关的重要问题。作为退伍军人管理局医院研发部的副主任， Benabe必须始终在该单位，但是，副主任卡洛斯卢西亚诺博士（35%）和助理主任Marcia Cruz博士（25%）允许其中一名主任经常在场，并协助P. D。在项目运作的各个方面。副项目主任担任与医学科学校园的教师和行政机制的联络人，促进该计划的目标和机构内的具体目标的实施。 临床研究咨询委员会（RCAC）在RCRII的董事中发挥了重要作用。RCAC由两个小组委员会组成，一个是由UPR-MSC的教师和调查人员组成的内部小组委员会，另一个是由我们的外部顾问Brater，Watkins和Palefsky博士组成的外部小组委员会。驻地协调员公署负责审批第二代总区进行的所有规程、甄选试验计划的程序、分配第二代总区的资源，以及监督第二代总区的运作和 RCRII的政策。它还向PI提供建议。以及科学计划的PD。 驻地协调员评估中心内部小组委员会每月举行会议，审查提交的规程和第二个驻地协调员区域中心的总体方向。委员会使用委员会制定和批准的标准格式评估每个方案，以解决RCRII方案相关的所有相关问题。每个方案由两名"主要"审查员审查，他们是委员会的投票成员，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提供额外输入。PD，助理 方案主任和助理方案主任作为无表决权成员出席驻地协调员评估中心的每月会议。他们讨论与RCRII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法规，审查所有新方案的数据和安全监测计划，并参与讨论和评估申请使用RCRII设施的所有新方案以及与其他计划的拟议合作。