Office of the Clinical Director

National Institute On Drug Abuse

Investigators

Linked publications & trials

Abstract

In 2020 the Office of the Clinical Director (OCD), Intramural Research Program (IRP), National Institute on Drug Abuse (NIDA), NIH provides clinical research support to three clinical research branches, the Clinical Pharmacology and Therapeutics Research Branch (CPTRB), the Translational Addiction Medicine Branch (TAMB), 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 staff includes an Administrative Professional who provides primary support to the Clinical Director and Deputy Clinical Director. The Administrative Professional also coordinates with the IRP Pharmacy, OCD contractors, 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. Four 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 6 full time Research Associates who are shared among PIs and supplement the study implementation conducted by the PIs and their teams. These positions are part of the clinical services provided through the Kelly Services Contract with NIDA/IRP. The OCD staff includes one counselor and one clinic manager who coordinate the Archway Outpatient Addiction Treatment Clinic. Through a contract with Johns Hopkins managed by the OCD, our 7 clinical PIs have access to an extensive clinical infrastructure and array of services including professional physician consultations, laboratory medicine, radiology, and emergency services, as well as inpatient facilities. The Addictions IRB was consolidated into the NIH IRB in Nov 2019. Two IRB staff were transitioned to support the OCD's Translational Research Initiative (TRI). In FY2019 a Protocol Navigator supported by the Office of Research Support and Compliance (ORSC) was added to coordinate with the consolidated NIH IRB and support the clinical PIs with protocol and regulatory actions. The OCD also supports the Data Safety and Monitoring Board (DSMB) which is comprised of external members including 2 statisticians, a secretary, and 4-6 outside experts in pharmacology, clinical research, neurobiology, and psychiatry. The DSMB meets quarterly to review moderate-risk and higher protocols and ensure patient safety and compliance with protocol monitoring and safety procedures. The OCD indirectly supports participant recruitment services including advertising, outreach, and remuneration for all NIDA IRP protocols by facilitating the management of the contracts with outside vendors selected by the clinical PIs to provide these services. The OCD directly supports the participant recruitment effort by providing phone and in-person participant screening through its team of 3 screeners, 2 counselors, and 2 Physician Assistants. 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 20 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. Since July 2020 the OCD has designed and implemented a staff asymptomatic SARS CoV2 testing system that includes registration/scheduling, specimen collection, delivery of samples to NIH Division of Laboratory Medicine, result reporting, and contact tracing for both NIDA and the NIA with whom we share a building. In December 2020 the OCD instituted a participant asymptomatic SARS CoV2 testing program. Additionally the OCD provides Basic Life Saving (BLS) training and certification, as well as naloxone overdose prevention training for the entire NIDA IRP including administrative, basic science, and clinical staff.