Clinical Research Core

临床研究核心

• 批准号: 8135412
• 负责人: HELEN E HESLOP
• 金额: $ 8.15万
• 依托单位: BAYLOR COLLEGE OF MEDICINE
• 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/8135412
• 关键词: Annual Reports; Clinical Research; Clinical Trials; Conduct Clinical Trials; Data; Data Collection; Enrollment; Ensure; Goals; Good Clinical Practice; Group Meetings; Human Resources; Monitor; Nurses; Nursing Research; Patients; Physicians; Procedures; Quality Control; Regulatory Affairs; Reproduction spores; Research; Research Ethics Committees; Research Infrastructure; Research Personnel; Review Committee; Safety; Services; Toxic effect; experience; programs; protocol development; quality assurance; research study

The goals of the cliniclal research core are to provide all projects with centralized clinical trial support and provide an infrastructure of personnel and services that will adequately support such research. Core services will be provided in regulatory affairs, study coordination, quality assurance and control and data safety monitoring. The Regulatory Affairs component collaborates with investigators to develop and submit all required regulatory documents, including submissions to the IRB, IBC, FDA, and NIH/ORDA and annual reports. This core has extensive experience with IND submission and currently supports over 25 IND studies. The Quality Control (QC) program will ensure that standard operating procedures for protocol development, conduct of clinical trials, data collection and management of clinical trials are accurately defined and being followed. The QA program will undertake audits after the first patient is enrolled on a study and then randomly to ensure that the studies are being conducted according to Good Clinical Practices. The core will also co-ordinate data monitoring by the Data Review Committee which is responsible for reviewing and evaluating toxicity and any other study-relevant safety-related data for clinical research studies in this SPORE. The core will also arrange internal group meetings of the investigators, attending physicians, statisticians, research nurse, data manager, and appropriate nurse managers to ensure that the clinical studies are conducted both safely and efficiently. It will also provide research nurse support to faciliate conduct of clinical trials.

临床研究中心的目标是为所有项目提供集中的临床试验支持和