NIDCR DIR Clinical Support Services

NIDCR DIR 临床支持服务

• 批准号: 9796021
• 负责人: Janice Lee
• 金额: $ 405.29万
• 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/9796021
• 关键词: Caring; Clinical; Clinical Protocols; Clinical Research; Clinical Research Protocols; Clinical Trials; Consultations; Data; Databases; Dental; Development; Goals; Hospitals; Institutes; Institutional Review Boards; Intranet; Maintenance; Medical; Monitor; National Institute of Dental and Craniofacial Research; Nursing Research; Oral Surgical Procedures; Patients; Performance; Procedures; Protocols documentation; Quality Control; Reporting; Safety; Schedule; Services; System; United States National Institutes of Health; Visit; Work; Writing; dental surgery; improved; operation; patient safety; research and development

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 FY18, the DCRC improved the support services for clinical research protocols through enhanced database development and management, intranet functionality, development of e-regulatory binders, and research nursing support. New clinical and patient safety activities were reviewed and added to overall services. A new Clinical Trials Management System project is in use this year. 2) Support clinical research quality and oversight through formal external study monitoring, Data Safety Monitoring Committee (DSMC) and internal quality controls In FY18, NIDCR supported a standing DSMC, internal quality monitoring, and other oversight activities for all clinical research. 3) Support the Institutional Review Board (IRB) In FY18, the NIDCR continued to work with the CNS IRB to improve protocol management and procedures for review through the efforts of the NIDCR Clinical Operations Manager, Ms. Tammy Yokum and Ms. Beth Brilliant. 4) Provide dental and oral surgery medical consultations for subjects in the Clinical Center, at NIDCR and at other NIH Institutes In FY18 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 remains stable in the last year. 5) Support the Clinical Director's (CD) Office In FY18, the DCRC supported the CD Office to facilitate clinical research development, clinical protocol performance and quality, maintenance of staff credentials and hospital privileges. The new CTMS project is ongoing and will improve clinical research oversight and management. 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18财年，DCRC改善了临床支持服务 通过增强数据库开发和管理，Intranet功能，电子调节粘合剂的开发以及研究护理支持的研究协议。 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。 今年正在使用一个新的临床试验管理系统项目。 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 在2018财年，NIDCR支持常规的DSMC，内部质量监测以及所有临床研究的其他监督活动。 3）支持机构审查委员会（IRB） 在2018财年，NIDCR继续与中枢神经系统IRB合作，通过NIDCR临床运营经理Tammy Yokum女士和Beth Brillirly女士的努力来改善协议管理和程序以进行审查。 4）为受试者提供牙科和口腔外科医学咨询 NIDCR和其他NIH机构的临床中心 在18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。去年，患者/受试者就诊的总数保持稳定。 5）支持临床主任（CD）办公室 在18财年，DCRC支持CD办公室，以促进临床研究开发，临床协议性能和质量，维护员工证书和医院特权。 新的CTMS项目正在进行中，并将改善临床研究的监督和管理。 CD已为受训者开发了一个跟踪数据库。