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Clinical Trial Operations Core

临床试验运营核心

基本信息

批准号：
10248313
负责人：
Annick Desjardins
金额：
$ 18.05万
依托单位：
DUKE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-24 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10248313
关键词：
Antigens Avastin Bioinformatics Biometry Bone Marrow Brain Brain Neoplasms Cancer Vaccines Case Report Form Clinic Clinical Clinical Data Clinical Management Clinical Research Clinical Trials Clinical Trials Design Collaborations Collection Conduct Clinical Trials Conflict of Interest Consent Databases Dedications Development Doctor of Medicine Doctor of Philosophy Documentation Enrollment Ensure Evaluation Family Federal Government Gliadel Glioblastoma Glioma Goals Health system Immune Immunologic Monitoring Individual Infrastructure Institutes Interdisciplinary Communication International Investigational Therapies Laboratories Laboratory Finding Leadership MGMT gene Malignant - descriptor Malignant Neoplasms Malignant neoplasm of brain Manuscripts Methodology Mutate Newly Diagnosed Pathology Patient Recruitments Patient-Focused Outcomes Patients Population Heterogeneity Preparation Primary Brain Neoplasms Procedures Process Protocols documentation Publications Regulatory T-Lymphocyte Research Research Design Research Support Safety Services Specialist T-Lymphocyte Therapeutic Clinical Trial Tissues Training Translating Translational Research Translations United States Food and Drug Administration Universities biobank cancer clinical trial career clinical material cost effective data acquisition data management electronic data follow up assessment improved innovation interdisciplinary collaboration meetings monocyte multidisciplinary neoantigen vaccine neuro-oncology operation patient population programs promoter protocol development quality assurance recruit screening temozolomide

项目摘要

ABSTRACT – Clinical Trial Operations Core (Core 2) The Clinical Trial Operations Core provides critical research support to promote seamless and efficient development, recruitment and conduct of the clinical trials in the Duke Brain SPORE's three projects and clinical studies proposed by Developmental and Career Enhancement awardees. Bringing strong expertise in neuro-oncology and clinical trial operations to the SPORE, the Core ensures the safe and efficient conduct of clinical studies (Aim 1) and recruitment, consent and enrollment of a diverse group of subjects for biospecimen collection and clinical studies (Aim 2). Through these Aims, the Core provides critical oversight of the full range of clinical trial activities, including study design, protocol preparation, research staff training, patient recruitment, patient evaluation during treatment and follow-up, assessment and treatment of complications, and evaluation of patient outcomes. To ensure rigorus trial conduct, the Core mainatins a full portfolio of standard operating procedures (SOPs). In addition, the Core is fully integrated with other Duke Brain SPORE components to ensure seamless research coordination. For example, in partnership with the Administrative Core, this Clinical Trial Operations Core provides regulatory specialists to meet the requirements of the federal government, Duke University Health System (DUHS), and Duke Cancer Institute (DCI) and avoid conflict of interest (COI). This Core also collaborates with the Biostatistics and Bioinformatics Core (Core 1) in the development of the protocol electronic case report forms (eCRFs), study database, data management, quality assurance, and summarization of clinical data for presentation at international meetings and manuscript publications. Finally, the Clinial Trial Operations Core supplies electronic data acquisition and documentation services for the Biostatistics and Bioinformatics Core (Core 1) and facilitates tissue biobanking with the Biospecimen and Immune Monitoring Core (Core 3). By enchancing interdisciplinary communictation and collaboration in this way, the Core supports the the SPORE's commitment to both translate laboratory findings to the clinic and collect clinical material to be studied in the laboratory.

临床试验操作核心（核心2）