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Clinical Protocol and Data Management

临床方案和数据管理

基本信息

批准号：
10454177
负责人：
Matthew Galsky
金额：
$ 28.04万
依托单位：
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-01 至 2025-07-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10454177
关键词：
Adult African American African American population Age Award Budgets Cancer Center Support Grant Cancer Patient Caring Catchment Area Child Childhood Clinical Clinical Data Clinical Nursing Research Clinical Protocols Clinical Research Clinical Trials Clinical Trials Data Monitoring Committees Communication Data Development Disease Enrollment Ensure Event Family Geographic Locations Geography Guidelines Hispanic Hispanic Populations Individual Institutes Intervention Lead Longevity Malignant Childhood Neoplasm Malignant Neoplasms Minority Minority Groups Minority Women Mission Monitor Monitoring Clinical Trials Oncologist Oncology Participant Patients Pediatric Hematology Pediatric Oncology Group Phase Population Protocols documentation Reporting Research Research Personnel Safety Structure Therapeutic Therapeutic Clinical Trial Therapeutic Intervention Therapeutic Trials TimeLine Training Training and Education Woman age group aged cancer care cancer clinical trial cancer therapy clinical trial enrollment data management evidence base high risk human old age (65+)innovation malignant breast neoplasm medical schools member minority patient multidisciplinary patient population recruit repository safety study sound

项目摘要

PROJECT SUMMARY/ABSTRACT Part I: Clinical Protocol and Data Management The primary mission of the Clinical Protocol and Data Management team, also referred to as the Cancer Clinical Trials Office (CCTO), is to assist Tisch Cancer Institute investigators in the development, conduct, and reporting of innovative clinical research in an efficient, regulatory-compliant, and scientifically sound manner. The CCTO comprises the following functions: study coordination, data management, regulatory management, pre-award budgeting, training and education. Part II: Data and Safety Monitoring All cancer clinical trials are monitored according to the guidelines set forth in the TCI Data and Safety Monitoring Plan (DSMP) which was previously reviewed and approved by the NCI. A formal Data and Safety Monitoring Committee (DSMC) was established in 2008 to ensure that investigator-initiated clinical trials in the TCI are compliant with the data and safety monitoring plans approved by the PRMC. The DSMC is accountable to and reports to the Associate Director for Clinical Research. Part III: Inclusion of Women and Minorities and Part IV: Inclusion Across the Lifespan TCI successfully recruits significant proportions of minority patients onto clinical trials. The TCI is highly committed to adhering to CCSG principles in providing state-of-the-art evidence-based, family-and-child- oriented, multi-disciplinary cancer treatment for women, minorities, and patients of all ages.

项目总结/文摘