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Adverse events reporting in Implementation science clinical trials

实施科学临床试验中的不良事件报告

基本信息

批准号：
10594131
负责人：
Tendani Gaolathe
金额：
$ 10.8万
依托单位：
UNIVERSITY OF BOTSWANA
依托单位国家：
美国
项目类别：
财政年份：
2020
资助国家：
美国
起止时间：
2020-09-15 至 2025-08-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10594131
关键词：
Administrator Adverse event Africa Africa South of the Sahara African Antihypertensive Agents Area Attitude Bioethics Consultants Clinical Trials Clinical Trials Design Country Delphi Technique Development Discipline Drug Industry Educational workshop Effectiveness Ensure Ethics Evidence based intervention Funding Funding Mechanisms Goals Guidelines HIV Health Health system Hybrids Institutional Review Boards International Intervention Intervention Studies Interview Journals Laboratory Finding Link Logic Logistics Marketing Methodology Methods Modeling Monitor Morbidity - disease rate National Heart, Lung, and Blood Institute Outcome Participant Patients Pharmaceutical Preparations Policies Policy Maker Policy Research Practice Guidelines Process Randomized Recommendation Records Regulation Reporting Research Research Design Research Methodology Research Personnel Research Project Grants Review Literature Risk Role Safety Secondary to Series Site Specific qualifier value System Testing Translational Research Work authority base cardiovascular health care delivery care outcomes cohort design effective intervention effectiveness study future implementation health care delivery implementation design implementation research implementation science improved informant interest intervention delivery meetings method development mortality pharmacovigilance primary outcome research study scale up side effect uptake virtual

项目摘要

PROJECT SUMMARY Our proposed work has the potential to develop differentiated, tailored adverse event reporting for implementation science clinical trial designs, especially if the role and focus of reporting may not be appropriately met using existing clinical trial adverse event reporting frameworks. Over the long term, these benefits are intended to “trickle” down to all implementation science clinical trials in Africa and any other parts of the world where efforts are required to ensure adequate and appropriate reporting of adverse events in implementation science clinical trials. Our results will be presented at local policy and professional development meetings, research meetings and international research such as journals and scientific gatherings.

项目摘要我们提出的工作有可能开发差异化的、量身定制的不良事件报告，实施科学的临床试验设计，特别是如果报告的作用和重点可能不是使用现有临床试验不良事件报告框架适当满足。从长远来看，这些这些好处旨在“涓滴”到非洲和其他任何国家的所有实施科学临床试验中，需要努力确保充分和适当地报告不利的实施科学临床试验中的事件。我们的研究结果将在当地的政策和专业发展会议，研究会议和国际研究，如期刊和科学聚会。