NIAID CLINICAL SITE MONITORING

NIAID 临床现场监测

• 批准号: 10556307
• 负责人: KIMBERLY SMITH
• 金额: $ 2252.55万
• 依托单位: PPD DEVELOPMENT LP
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10556307
• 关键词: AIDS/HIV problem; Acquired Immunodeficiency Syndrome; Address; Adherence; Clinical; Clinical Research; Clinical Trials; Clinical Trials Network; Contractor; Contracts; Country; Data; Development; Ensure; Grant; Guidelines; HIV Infections; HIV therapy; HIV vaccine; Investigation; Modality; Monitor; National Institute of Allergy and Infectious Disease; Performance; Pharmacy facility; Phase; Prevention Measures; Preventive; Procedures; Process; Protocols documentation; Quality Control; Recommendation; Records; Reporting; Research; Research Project Grants; Research Support; Safety; Services; Site; Site Visit; System; Treatment Efficacy; Vaccines; Visit; clinical research site; clinical trial implementation; operation; public health emergency; quality assurance; response

The National Institute of Allergy and Infectious Diseases, Division of Acquired Immunodeficiency Syndrome (DAIDS) supports the advancement of therapies for HIV infection and its complications, and supports the development of HIV/AIDS vaccines and other prevention measures. Through grants and contracts, DAIDS sponsors Phase I, II, III and IV clinical trials to evaluate the safety and efficacy of therapeutics, vaccines and other preventive modalities. The purpose of the Clinical Site Monitoring contract will be to continue to provide comprehensive clinical site and study monitoring services for the NIAID/DAIDS clinical trial research portfolio, including the delivery of monitoring services for unanticipated DAIDS clinical research projects that may be required in response to emerging needs or public health emergencies.

国家过敏症和传染病研究所获得性免疫缺陷综合症处支持改进艾滋病毒感染及其并发症的治疗方法，并支持开发艾滋病毒/艾滋病疫苗和其他预防措施。 通过赠款和合同，艾滋病司赞助第一、第二、第三和第四期临床试验，以评估治疗、疫苗和其他预防方式的安全性和有效性。 临床研究中心监查合同的目的是继续为NIAID/DAIDS临床试验研究组合提供全面的临床研究中心和研究监查服务，包括为应对新出现的需求或突发公共卫生事件可能需要的非预期DAIDS临床研究项目提供监查服务。