Office of the Clinical Director

National Institute On Drug Abuse

Investigators

Linked publications, trials & patents

Abstract

The Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides clinical research support to two clinical research branches, the Clinical Pharmacology and Therapeutics Research Branch (CPTRB) and the Neuroimaging Research Branch (NRB). The scope of the research program is broad and is strongly represented in the behavioral and pharmacological treatments for opioid use disorder and other substance use disorders as well as non-invasive brain stimulation and neuroimaging. The Office of the Clinical Director has a staff of an Administrative Assistant who provides primary support to the Clinical Director and 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. In April 2019 the OCD added a Staff Clinician in order to meet the growing clinical needs resulting from the addition of a new tenure track clinical investigator in Jan 2019 and a tenured clinical investigator in July 2019. The 2 full time Mid-Level Providers (Federal) medically screen potential participants as well as assist in the day to day running of various protocols. Three full time nurses also staff and run protocols and ensure patient safety and quality clinical care. Additional clinical staff supporting the NIDA/IRP clinical program includes 4 full time Research Associates. These positions are part of the clinical services provided through the Kelly Services Contract with NIDA/IRP. Due to a reorganization of the clinical program in Jan 2018, 2 additional RAs and 3 additional nurses were brought under the OCD from the CPTRB as well as one counselor and one clinic manager. Of these 3 contract nurses, one nurse retired in FY2018 and was not replaced and a second nurse left NIDA in August 2019 due to dissolution of the contract through which she was hired, leaving 3 FTE nurses and 1 contract nurse in the OCD by the end of FY2019. Through a contract with JHBMC (Johns Hopkins Bayview Medical Campus) managed by the OCD, our 6 clinical PIs have access to an extensive clinical infrastructure and array of services including professional physician consultations, laboratory medicine, radiology, and emergency services. 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). In FY2019 a Protocol Navigator supported by the Office of Research Support and Compliance (ORSC) was added to the team. The IRB office handles approximately 400 IRB related actions a year, from about 50 active protocols (21 from NIDA). The Addictions IRB serves both NIDA and NIAAA. The OCD also supports the Data Safety and Monitoring Board (DSMB) which is comprised of a statistician, a secretary, and 4-6 outside experts in pharmacology, clinical research, neurobiology, and psychiatry. The DSMB meets quarterly to review protocols and ensure patient safety and compliance with protocol monitoring and safety procedures. The OCD oversees a contract with MMG which provides advertising, recruiting and, research participant screening for all NIDA IRP protocols in the Baltimore Washington area. At this time MMG employs 6 screening specialists, 2 participant counselors, 1 medical assistant and an on-site manager. The Medical Records Department at NIDA/IRP is designed to maintain department compliance of Policy and Procedures while safekeeping the Privacy of over 6600 electronic (HuRIS System) medical records annually. Hardcopy documents of the medical records currently include signed consents and outside medical records; otherwise everything is electronic. Some older charts are available on microfilm. We continue to broaden our use of electronic consent and quiz procedures in our studies which further enhances our digital profile. 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 NIDA IRP Pharmacy employs two full time pharmacists and one pharmacy technician. The NIDA IRP pharmacy currently supports about 21 clinical studies including opioid and other drug addiction treatment studies and 40 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.