Office of the Clinical Director

临床主任办公室

• 批准号: 8736971
• 负责人: Markus Heilig
• 金额: $ 500.11万
• 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/8736971
• 关键词: Administrator; Advertising; Area; Baltimore; Behavior Therapy; Biological Assay; Budgets; Chemistry; Clinical; Clinical Protocols; Clinical Research; Clinical Services; Clinical Trials Data Monitoring Committees; Consultations; Contracts; Discipline of Nursing; Disease; Drug Kinetics; Drug Monitoring; Electronics; Equipment and supply inventories; Genomics; Genotype; Housing; Inpatients; Institutional Review Boards; Internet; Intramural Research Program; Laboratories; Licensing; Medical; Medical Records; Medicine; Microfilm; Microfilming; National Institute of Drug Abuse; National Institute on Alcohol Abuse and Alcoholism; Participant; Patients; Pharmaceutical Preparations; Pharmacists; Pharmacological Treatment; Pharmacy facility; Phenotype; 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 Subjects; Research Support; Running; Safety; Services; Source; Specialist; Substance abuse problem; System; Television; Time; Toxicology; Transcranial magnetic stimulation; United States National Institutes of Health; Universities; Washington; addiction; base; clinical infrastructure; cost; design; innovation; 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 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 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 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. The Addictions IRB, which serves both NIDA and NIAAA continues to answer to the OHSRP. The OCD oversees a contract with MMG, an outside organization. MMG represents NIDA/IRP, recruiting research participants in the Baltimore Washington area. At this time MMG employs 8 screening specialists, 2 patient 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. 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 two full time pharmacists and one pharmacy technician. The IRP pharmacy currently supports about 15 clinical studies including 5 Archway studies and 70 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.

临床主任办公室（OCD），校内研究计划（IRP），国家药物滥用研究所（NIDA），美国国立卫生研究院为IRP的两个临床研究分支提供研究支持。研究项目的范围很广，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学治疗方面有很强的代表性。