NIDCR DIR Clinical Support Services

NIDCR DIR 临床支持服务

• 批准号: 10932030
• 负责人: Janice Lee
• 金额: $ 562.47万
• 依托单位: NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
• 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/10932030
• 关键词: Back; Biometry; COVID-19 pandemic; Caring; Clinic; Clinical; Clinical Protocols; Clinical Research; Clinical Research Protocols; Consultations; Credentialing; Data; Databases; Dental; Dental Staff; Development; Emergency Situation; Epidemiology; Goals; Hospitals; Infection Control; Institutional Review Boards; Maintenance; Measures; Metabolic Bone Diseases; Monitor; National Institute of Dental and Craniofacial Research; Nursing Research; Oral Surgical Procedures; Patients; Performance; Process; Protocols documentation; Quality Control; Reporting; Research; Research Support; Safety; Saliva; Schedule; Services; Study Subject; United States National Institutes of Health; Visit; Writing; clinical center; coronavirus disease; dental surgery; human subject; improved; operation; patient safety; pre-pandemic; research and development; simulation; virtual

1) Support the clinical research at NIDCR DIR through assistance with protocol writing, scientific reviewing, regulatory compliance (FDA and OHRP), database development, AE/SAE reporting, subject scheduling, study coordinator support and research nursing support In FY23, the DCRC improved the support services for clinical research protocols through enhanced database development and management, virtual office processes, development of new scientific review processes, and new biostatistical support. New clinical and patient safety activities were reviewed and added to overall services, including regular weekly clinic huddles and continuation of biannual emergency simulations. Partnership and increased utilization of the Office of Research Support and Coordination (CC) for support of human subject studies. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls. Efficient study monitoring through partnership with OCTOM was maintained. In FY23, NIDCR supported additional DSMCs, internal quality monitoring, and other oversight activities for all clinical research. All studies have been in compliance, including the newly initiated COVID Saliva study. Most monitoring efforts have been conducted remotely during the COVID pandemic. NIDCR studies are FDAA reporting compliant. 3) Support the Institutional Review Board (IRB) In FY23, the NIDCR human subject protocols are overseen by the central NIH IRB. Protocol navigation, research oversight and monitoring was improved through the efforts of the NIDCR Clinical Operations Manager, Ms. Beth Brilliant and study navigation with Rachel Wagner and Ingrid Espinoza. All studies continue to have appropriate scientific review and institute review. 4) Provide dental and oral surgery and metabolic bone diseases consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY23 the NIDCR clinical staff supported NIDCR DIR clinical research and provided oral surgery and dental consultations and care to other NIH institutes. The overall number of patient/subject visits is nearly back to pre-pandemic levels. The hospital dental staff have implemented several infection control and safety measures with the support of Hospital Epidemiology Service. 5) Support through the Office of the Clinical Director (OCD) In FY23, the OCD continues to facilitate clinical research development, clinical protocol performance and quality, maintenance of staff credentials and hospital privileges. The CD has developed a tracking database for trainees.

1）通过协助支持NIDCR DIR的临床研究 通过协议写作，科学审查，法规合规性（FDA） 和OHRP），数据库开发，AE/SAE报告，主题调度， 研究协调员支持和研究护理支持 在23财年，DCRC改善了临床支持服务 通过增强数据库开发和管理，虚拟办公流程，新科学审查过程的开发以及新的生物统计支持的研究协议。 审查了新的临床和患者安全活动，并将其添加到整体服务中，包括定期的每周诊所杂货店以及延续双年度紧急模拟。 伙伴关系和增加研究支持和协调办公室的利用（CC）来支持人类学科研究。 2）通过正式外部支持临床研究质量和监督 研究监测，数据安全监测委员会（DSMC）和内部 质量控制。 通过与OCTOM合作进行有效的研究监测。 在23财年，NIDCR支持其他DSMC，内部质量监测以及所有临床研究的其他监督活动。 所有研究都符合依从性，包括新启动的Covid Saliva研究。 大多数监测工作是在共同大流行期间远程进行的。 NIDCR研究符合FDAA报告。 3）支持机构审查委员会（IRB） 在23财年，NIDCR人类主题方案由中央NIH IRB监督。 通过NIDCR临床运营经理贝丝·布莱特（Beth Brilliant）和雷切尔·瓦格纳（Rachel Wagner）和英格丽（Ingrid Espinoza）的研究导航，协议导航，研究监督和监测得到了改善。 所有研究继续进行适当的科学审查和审查。 4）为受试者提供牙科和口腔手术以及代谢骨疾病咨询 NIDCR和其他NIH机构的临床中心 在23财年，NIDCR临床人员支持NIDCR DIR临床研究并提供了口头 手术和牙科咨询，并向其他NIH机构提供护理。患者/受试者访问的总数几乎恢复到了学前水平。 医院牙科人员在医院流行病学服务的支持下实施了多种感染控制和安全措施。 5）通过临床主任办公室（OCD）的支持 在23财年，OCD继续促进临床研究开发，临床方案绩效和质量，维护员工证书和医院特权。 CD已为受训者开发了一个跟踪数据库。

项目成果

Quantitative salivary proteomic differences in oral chronic graft-versus-host disease.

• DOI: 10.1007/s10875-012-9738-4
• 发表时间: 2012-12
• 期刊: JOURNAL OF CLINICAL IMMUNOLOGY
• 影响因子: 9.1
• 作者: Bassim, Carol W.;Ambatipudi, Kiran S.;Mays, Jacqueline W.;Edwards, Dean A.;Swatkoski, Stephan;Fassil, Helen;Baird, Kristin;Gucek, Marjan;Melvin, James E.;Pavletic, Steven Z.
• 通讯作者: Pavletic, Steven Z.