Office of the Clinical Director

临床主任办公室

• 批准号: 8933901
• 负责人: ANTONELLO BONCI
• 金额: $ 580.47万
• 依托单位: NATIONAL INSTITUTE ON DRUG ABUSE
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8933901
• 关键词: Administrator; Advertising; Area; Baltimore; Behavior Therapy; Budgets; Chemistry; Clinical; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Consent; Consultations; Contractor; Contracts; Discipline of Nursing; Disease; Drug Kinetics; Drug Monitoring; Electronics; Equipment and supply inventories; Human Subject Research; Inpatients; Institutional Review Boards; Internet; Intramural Research Program; Laboratories; Licensing; Medical; Medical Records; Medical center; Medicine; Microfilm; Microfilming; National Institute of Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; Participant; Pharmaceutical Preparations; Pharmacists; Pharmacological Treatment; Pharmacy facility; Physicians; Policy Compliance; Positioning Attribute; Postdoctoral Fellow; Printing; Privacy; Privacy Act; Procedures; Process; Professional counselor; Protocols documentation; Provider; Radio; Recruitment Activity; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Running; Safety; Services; Specialist; Substance abuse problem; System; Television; Time; Toxicology; Uncertainty; United States National Institutes of Health; Washington; addiction; design; meetings; member; neuroimaging; programs; protocol development; research study; screening; Administrator; Advertising; Area; Baltimore; Behavior Therapy; Budgets; Chemistry; Clinical; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Consent; Consultations; Contractor; Contracts; Discipline of Nursing; Disease; Drug Kinetics; Drug Monitoring; Electronics; Equipment and supply inventories; Human Subject Research; Inpatients; Institutional Review Boards; Internet; Intramural Research Program; Laboratories; Licensing; Medical; Medical Records; Medical center; Medicine; Microfilm; Microfilming; National Institute of Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; Participant; Pharmaceutical Preparations; Pharmacists; Pharmacological Treatment; Pharmacy facility; Physicians; Policy Compliance; Positioning Attribute; Postdoctoral Fellow; Printing; Privacy; Privacy Act; Procedures; Process; Professional counselor; Protocols documentation; Provider; Radio; Recruitment Activity; Regulation; Reporting; Research; Research Infrastructure; Research Personnel; Research Support; Running; Safety; Services; Specialist; Substance abuse problem; System; Television; Time; Toxicology; Uncertainty; United States National Institutes of Health; Washington; addiction; design; meetings; member; neuroimaging; programs; protocol development; research study; screening

The Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides research support to two clinical research branches at the IRP. The scope of the research program is broad and is strongly represented in neuroimaging, as well as behavioral and pharmacological treatments for substance abuse disorders and chemistry / toxicology. The Office of the Clinical Director has a staff of an Administrative Assistant who provides primary support to the Acting Clinical Director and Acting Deputy Clinical Director. This Administrative Assistant also coordinates with the IRP Pharmacy, Matthews Media Group, Inc. (MMG), Medical Records Department, the Mid-Level Providers and Nursing. The three full time Mid-Level Providers (Federal) medically screen potential participants as well as assist in the day to day running of various protocols. Four full time RNs provide the staffing for running the protocols. Additional Clinical staff supporting the NIDA/IRP programs includes 4 full time Research Associates. These positions are part of the clinical services provided through the Johns Hopkins Bayview Medical Contract with NIDA/IRP. This contract also provides essential infrastructure and services including professional physician consultations, laboratory medicine and staff support as well as overnights for subjects at Clinical Research Unit (CRU) located on the Bayview campus. The Addictions IRB, while under the direction of the NIH Office of Human Subjects Research Protections (OHSRP) is supported by the OCD. Staffing includes an IRB Administrator (Federal) with assistance from two other staff members (1 Federal and 1 contractor). The office handles approximately 400 IRB related actions a year, from 58 active protocols. The Addictions IRB serves both NIDA and NIAAA. The OCD oversees a contract with MMG, an outside organization. MMG represents NIDA/IRP, recruiting and screening research participants in the Baltimore Washington area. At this time MMG employs 7 screening specialists, 2 participant counselors, 1 medical assistant and a 2 member management team. There is a yearly budget of $246,000 for print, web, radio and television advertising and $35,000 for materials for recruiting. The Medical Records Department at NIDA/IRP is designed to maintain department compliance of Policy and Procedures while safekeeping the Privacy of over 6300 electronic (HuRIS System) medical records annually. Hardcopy documents of the medical records currently include ECGs, signed consents and outside medical records; otherwise everything is electronic. Some older charts are available on microfilm. This is done according to the National Institute of Health, Federal and State Rules and Regulations (Including the Privacy Act of 1974 and HIPPA). The IRP Pharmacy employs two full time pharmacists and one pharmacy technician. The IRP pharmacy currently supports about 16 clinical studies including 3 Archway studies and 100 researchers/labs for nonclinical studies. One pharmacist devotes about 80% of her time supporting the clinical studies and 20 % nonclinical studies. The other pharmacist spends about 50 % effort on clinical and 50 % effort on nonclinical studies. Clinical research support includes reviewing, preparing, compounding, and dispensing the study medications. Nonclinical support includes ordering, compounding, dispensing, and laboratory auditing. In addition, the pharmacy monitors drug inventories, and meets all DEA and FDA regulatory requirements including licensing and IND reporting.

NIH国家药物滥用研究所（NIDA）临床主任办公室（OCD）办公室（IRP）为IRP的两个临床研究部门提供了研究支持。该研究计划的范围很广，并且在神经影像学以及药物滥用障碍和化学 /毒理学的行为和药理治疗中得到了强烈的代表。 临床主任办公室有一名行政助理的工作人员，他为代理临床主任和代理副临床主任提供主要支持。这位行政助理还与IRP药房Matthews Media Group，Inc。（MMG），医疗记录部，中级提供商和护理协调。三个全职中级提供商（联邦）医学上的潜在参与者以及各种协议的日常运行。四个全职RN提供了运行协议的人员。支持NIDA/IRP计划的其他临床人员包括4位全日制研究助理。这些职位是通过与NIDA/IRP的Johns Hopkins Bayview医疗合同提供的临床服务的一部分。该合同还提供了必不可少的基础设施和服务，包括专业医师咨询，实验室医学和员工支持以及位于Bayview校园的临床研究部门（CRU）过夜。 OCD支持成瘾IRB，虽然在NIH人类受试者的研究保护（OHSRP）的指导下。人员配备包括在另外两名员工（1名联邦和1名承包商）的协助下的IRB管理员（联邦）。该办公室每年从58个主动协议中处理大约400个IRB相关行为。成瘾IRB同时为NIDA和NIAAA服务。 OCD监督与外部组织MMG的合同。 MMG代表NIDA/IRP，巴尔的摩华盛顿地区的招聘和筛选研究参与者。此时，MMG雇用了7名筛查专家，2名参与者辅导员，1名医疗助理和2个成员管理团队。印刷，网络，广播和电视广告的年度预算为246,000美元，招募材料的预算为35,000美元。 NIDA/IRP的医疗记录部旨在维护部门对政策和程序的合规性，同时每年保护6300多个电子（Huris System）医疗记录的隐私。 目前，医疗记录的硬拷贝文件包括心电图，签署的同意书和外部病历；否则一切都是电子的。一些较旧的图表可在缩微胶卷上找到。 这是根据美国国家卫生研究院，联邦和州规则和法规（包括1974年的《隐私法》和《河马》）进行的。 IRP药房雇用两名全职药剂师和一名药房技术员。 IRP药房目前支持大约16项临床研究，其中包括3项拱门研究和100名研究人员/实验室，用于非临床研究。一位药剂师将约80％的时间用于支持临床研究和20％的非临床研究。其他药剂师在临床上花费了约50％的努力，而在非临床研究上花费了50％。临床研究支持包括审查，准备，复合和分配研究药物。非临床支持包括订购，复合，分配和实验室审核。此外，药房监视药品清单，并满足所有DEA和FDA监管要求，包括许可和IND报告。