Clinical Operations and Procedures Core

临床操作和程序核心

• 批准号: 10507630
• 负责人: Marinella Temprosa
• 金额: $ 1205.55万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10507630
• 关键词: Alzheimer' s Disease; Alzheimer' s disease related dementia; Amyloid; Biochemistry; Biological Assay; Biological Markers; Biometry; Brain imaging; Cardiology; Cardiovascular Diseases; Cardiovascular system; Cerebrovascular Disorders; Certification; Cessation of life; Clinical; Cognition; Cognitive; Collection; Communities; Data; Data Collection; Diagnostic; Disease Outcome; Electrocardiogram; Ensure; Epidemiology; Event; Goals; Hospitalization; Laboratories; Leadership; Manuals; Measurement; Measures; Medicine; Minnesota; Monitor; National Institute on Aging; Neuropathy; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outcome Study; Participant; Performance; Persons; Phase; Physical Function; Physical activity; Plasma; Prediabetes syndrome; Procedures; Process; Protocols documentation; Quality Control; Reading; Reporting; Research; Research Personnel; Risk Factors; Sampling; Schedule; Shipping; Ships; Specimen; Standardization; Stroke; Supervision; Time; Training; Universities; Vendor; Visit; Washington; Work; adjudicate; adjudication; clinical center; clinical research site; clinically significant; cognitive testing; college; data standards; diabetes control; diabetes prevention program; extracellular vesicles; forest; meetings; neuroimaging; operation; participant retention; programs; remote visit; success; virtual; web site

The goal of the Clinical Operations and Procedures Core (Clinical Core) of the Diabetes Prevention Program Outcomes Study (DPPOS) Alzheimer’s Disease (AD) and AD related dementias (ADRD) Project is to supervise training, certification, and quality control (QC) of the procedures and measures from the current phase of DPPOS, with the exception of legacy cognitive measures, that will be continued during DPPOS AD/ADRD. Cognitive procedures and measures are covered in the Cognitive Assessment and Adjudication Core (Cognition Core), and neuroimaging and AD/ADRD plasma biomarkers measures are covered in the Neuroimaging and Plasma Biomarkers Core (Biomarkers Core). The Clinical Core will facilitate and oversee all data collection procedures at the 25 clinical centers and support the DPPOS Central Biochemistry Laboratory (CBL) at the Advanced Research and Diagnostics Laboratory (ARDL, University of Minnesota), the electrocardiogram (ECG) Reading Center (Epidemiological Cardiology Research Center [EPICARE], Wake Forest University), and a vendor performing remote visits. The Clinical Core will follow the same rigorous procedures for staff training, and monitoring of clinical centers, the laboratory, the ECG reading center and the vendor performing remote participant visits as has successfully been done for the past 25 years in DPP/DPPOS. The long-term success of the DPPOS is due in large part to these longstanding operations, which will continue in the DPPOS AD/ADRD Project. The Clinical Core will achieve its goals through the following specific aims: (1) Provide oversight and management of all DPPOS clinical sites, including ensuring participant retention and timely completion of visits, monitoring completion and quality of participant study assessments and procedures, managing all study manuals and related documents; (2) Coordinate training and certification of clinical site staff in standardized measurements including physical function and activity, neuropathy, anthropometric measures and vital signs, cardiovascular and cerebrovascular disease outcomes, and collection of laboratory specimens; (3) Support the CBL at ARDL where biospecimens are shipped from the clinical centers, stored, and all core laboratory assays are measured, (except AD plasma biomarkers) , and biospecimens are shipped to Dr. Zetterberg at the University of Gothenburg to measure AD plasma biomarkers, and Dr. Kapogiannis at the National Institute on Aging for extraction of extracellular vesicles; (4) Support the ECG reading center at EPICARE, that will obtain participants’ hospitalization ECG recordings from study staff and provide ECG reading and interpretation to the Clinical Outcomes Adjudication team; (5) Support a Clinical Outcomes Adjudication committee that will adjudicate clinical outcomes and procure all available clinical brain imaging reports from participants; (6) Report clinically significant results to participants.

糖尿病预防计划的临床操作和程序核心(临床核心)的目标 结果研究(DPPOS)阿尔茨海默病(AD)和AD相关痴呆(ADRD)项目是监督 DPPOS当前阶段的程序和措施的培训、认证和质量控制(QC)； 除遗留认知措施外，这将在DPPOS AD/ADRD期间继续进行。认知 程序和措施包括在认知评估和裁决核心(认知核心)中， 神经成像和AD/ADRD血浆生物标记物的测量包括在神经成像和血浆中 生物标志物核心(Biomarkers Core)。临床核心将促进和监督所有数据收集程序 在25个临床中心，并支持DPPOS中心生物化学实验室(CBL)在高级 研究和诊断实验室(ARDL，明尼苏达大学)，心电(ECG)读数 中心(维克森林大学流行病学心脏病研究中心[EPICARE])和供应商 执行远程访问。临床核心将遵循同样严格的工作人员培训程序，以及 监测临床中心、实验室、心电读数中心和远程执行的供应商 过去25年来，政治部/政治部成功地进行了参与者访问。的长期成功 政治部很大程度上是由于这些长期业务，这些业务将在政治部AD/ADRD继续进行 项目。临床核心将通过以下具体目标实现其目标：(1)提供监督和 管理所有DPPOS临床站点，包括确保保留参与者并及时完成访问， 监测参与者研究评估和程序的完成情况和质量，管理所有研究手册 和相关文件；(2)协调临床现场工作人员的标准化培训和认证 测量包括身体功能和活动、神经病变、人体测量和生命体征， 心脑血管疾病结果和实验室标本收集；(3)支持 ARDL的CBL，生物样品从临床中心运到这里，储存和所有核心实验室分析 (AD血浆生物标记物除外)，生物标记物被运往大学的泽特伯格博士手中 哥德堡的Kapogiannis博士测量AD血浆生物标记物，以及国家老龄化研究所的Kapogiannis博士 提取细胞外小泡；(4)支持EPICARE的心电读取中心，该中心将获得参与者的 研究人员的住院心电记录，并为临床提供心电读数和解释 结果裁决小组；(5)支持将裁决临床结果的临床结果裁决委员会 结果并从参与者那里获得所有可用的临床脑成像报告；(6)临床报告 对参与者来说，这一结果意义重大。