Office of the Clinical Director

美国国立卫生研究院药物滥用研究所（NIDA）内部研究计划（IRP）的临床主任办公室（OCD）为IRP的两个临床研究分支提供研究支持。该研究计划的范围很广，在神经影像学方面有很强的代表性，同时还结合了药物滥用障碍的行为和药理学治疗。 临床主任办公室有一名行政助理，为主任和副主任提供主要支持。该行政助理还与IRP药房，马修斯媒体集团，公司协调。(MMG)，医疗记录部门，中层供应商和护理。三名全职中层提供者（联邦）对潜在参与者进行医学筛选，并协助各种方案的日常运行。四名全职RN提供运行协议的人员配置。支持NDA/IRP计划的其他临床工作人员包括5名全职研究助理。这些职位是通过约翰霍普金斯湾景医疗合同与NIDA/IRP提供的临床服务的一部分。该合同还提供必要的基础设施和服务，包括专业医生咨询，实验室医学和工作人员支持，以及位于Bayview校园的行为药理学研究单位（BPRU）的受试者过夜。 NIDA IRB办公室由OCD领导，并配备IRB管理员（联邦）。该办公室每年处理大约400项IRB相关行动，涉及40项现行方案。今年，IRB办公室与NIAAA一起组成了成瘾IRB，该机构继续对OHRP负责。 OCD监督与外部组织MMG签订的资金充足的合同。MMG代表NIDA/IRP，在巴尔的摩华盛顿地区招募研究人员。目前，MMG拥有13名筛查专家，2名患者顾问和3名管理团队成员。每年的预算为225 000美元，用于印刷、网络、广播和电视广告，50 000美元用于社区外联。 NIDA/IRP的医疗记录部门旨在维护部门对政策和程序的合规性，同时每年保护6300多份电子（HuRIS系统）医疗记录的隐私。内部和外部来源均可查阅医疗记录的缩微胶片和/或DVD以及硬拷贝。这是根据国家卫生研究所，联邦和州的规则和条例（包括1974年的隐私法和HIPPA）。 IRP药房雇用了三名全职药剂师。IRP药房目前支持约20项临床研究，包括5项Archway研究和70项非临床研究的研究人员/实验室。一位药剂师投入了大约80%的时间支持Archway研究，包括IND支持。另外两名药剂师大约60%的精力用于临床研究，40%的精力用于非临床研究。临床研究支持包括审查、准备、配制和分发研究药物。非临床支持包括订购、配制、配药和实验室稽查。此外，药房监测药物库存，并满足所有DEA和FDA的监管要求，包括许可和IND报告。 最近，OCD成立了法规事务办公室。法规事务官监督所有研究是否符合地方、联邦和NIH指南。该全职联邦员工与IRB、DSMB（数据安全和监测委员会）和外部承包商合作，以满足监测需求。

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, while also incorporating both behavioral and pharmacological treatments for substance abuse disorders. The Office of the Clinical Director has a staff of an Administrative Assistant who provides primary support to the Director and Deputy 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 NDA/IRP programs include 5 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 Behavioral Pharmacological Research Unit (BPRU) located on the Bayview campus. The NIDA IRB office is under the direction of the OCD and is staffed by an IRB Administrator (Federal). The office handles approximately 400 IRB related actions a year, from 40 active protocols. This year the IRB office has joined with the NIAAA forming the Addictions IRB which continues to answer to the OHRP. The OCD oversees a fully funded contract with MMG, an outside organization. MMG represents NIDA/IRP, recruiting research participants in the Baltimore Washington area. At this time MMG employs 13 screening specialists, 2 patient counselors and a 3 member management team. There is a yearly budget of $225,000 for print, web, radio and television advertising and $50,000 for community outreach. 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. Both microfilm and/or DVD as well as hardcopy versions of the medical records are accessed for both in-house and outside sources. 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 three full time pharmacists. The IRP pharmacy currently supports about 20 clinical studies including 5 Archway studies and 70 researchers/labs for nonclinical studies. One pharmacist devotes about 80% of her time supporting the Archway studies, including IND support. The other two pharmacist spends about 60 % effort on clinical and 40 % 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. Recently the OCD established the Office of Regulatory Affairs. The Regulatory Affairs Officer oversees the compliance of all research for local, federal and NIH guidelines. That full time Federal employee works with the IRB, DSMB (Data Safety and Monitoring Board)and outside contractors to fulfill monitoring needs.