使用REDCap数据收集系统简化严重不良事件 (SAE) 的电子报告:eSAE项目
Joanna Black1, Patrick Julier2, Lucy Eldridge2
1Oxford Clinical Trials Research Unit (OCTRU), Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, OX3 7LF, UK. joanna.black@ndorms.ox.ac.uk.
Trials
|July 23, 2024
概括
一个新的REDCap模块简化了临床试验中的严重不良事件 (SAE) 报告. 通过自动填充数据和突出更新以及时审查赞助商,eSAE项目减少了错误和延迟.
科学领域:
- 临床试验技术 临床试验技术
- 药监系统 药监系统 药监系统
- 研究中的法规合规性
背景情况:
- 电子数据收集 (EDC) 系统必须确保符合法规和良好的临床实践 (GCP) 准确的安全数据报告.
- 关于严重不良事件 (SAE) 和疑似意外严重不良反应 (SUSAR) 的及时报告在临床试验药物 (CTIMP) 的临床试验中至关重要.
- 对SEs的不良事件 (AE) 数据的手动重新输入引入了错误和报告延迟的风险.
研究的目的:
- 在英国学术临床试验部门内开发一个高效的电子系统来管理SAE.
- 通过使用开源EDC系统,加强CTIMP中安全数据的及时和准确报告.
主要方法:
- 一个多学科团队在REDCap EDC系统中开发了一个模块.
- 该模块集成了AE和SAE报告功能.
- 嵌入式代码用于数据更新的视觉跟踪.
主要成果:
- 在REDCap中创建了一个电子SAE报告模块,自动触发AE表单中的SAE表单.
- 在SAE表格中预先填写相关字段可以最大限度地减少数据输入错误和延迟.
- 嵌入式功能提供数据更新的即时视觉识别,促进及时的赞助商审查和解决方案.
结论:
- 在REDCap中的eSAE项目提供了一种新的SAE报告方法,即自动填写最初AE表格中的数据.
- 该系统突出显示SEA的更新,使赞助商能够有效地重新评估和处理信息.
- 这提高了对临床试验的英国监管报告要求的遵守.
相关概念视频
Types of Reports II: Incident or Occurrence Report
810
An Incident or Occurrence Report in a healthcare setting is a crucial document used to record any unexpected occurrence that may or may not have affected a patient, employee, or visitor. Such reports are critical to improving patient safety and include all details leading up to and including the event.
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
Purposes:
In the healthcare industry, reports play a crucial role in documenting incidents within an agency. The primary objective of these reports is to ensure patient safety, uphold the...
810
Data Reporting and Recording
4.6K
Reporting and recording are crucial in data documentation. The timely, thorough, and accurate documentation of facts is essential when recording patient data. Failure to record findings during an assessment or interpretation of a problem will result in loss of information and make the patient document unreliable. The reader is left with general impressions if the information is not specific. A recording is documenting data of the individual's health information in a traceable, secure, and...
4.6K
Methods of Documentation VII: EMR
829
Electronic Medical Records (EMRs) primarily center around electronically documenting patients' health information within a single healthcare organization or practice. They contain essential clinical data related to a patient's medical history, diagnoses, medications, treatment plans, lab results, and other pertinent information relevant to the specific encounter or episode of care. EMRs are designed to streamline documentation and workflow processes within individual healthcare...
829
Guidelines and Strategies for Safe Computer Charting
798
The guidelines and strategies provided by the American Nurses Association (ANA) and the Canadian Nurses Association (CNA) offer essential principles for ensuring safe and secure computer charting systems in healthcare settings. Let's break down each recommendation:
Maintain Confidentiality and Security:
Maintain Confidentiality and Security:
798
SBAR II: Application of SBAR
4.4K
SBAR is an effective communication tool used by healthcare professionals to communicate patient information accurately. SBAR stands for Situation, Background, Assessment, and Recommendation. For a better understanding, an example is given below.
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
SBAR Report from a Nurse to a Health Care Provider
S: "Hello, Dr. Smith. This is Jane, RN, from the Med Surg unit. I am calling to tell you about Ms. White in Room 210, who is experiencing increased pain and redness at her incision site. Her recent...
4.4K
Introduction to Documentation and Reporting
2.0K
Documentation is the systematic process of formally recording, maintaining, and communicating information.
Nursing documentation records essential information and details regarding a patient's care and treatment in written or electronic form. It is a critical aspect of nursing practice that involves documenting assessments, interventions, outcomes, and other relevant details about a patient's health status.
Documentation maps the patient's health journey by creating a comprehensive...
Nursing documentation records essential information and details regarding a patient's care and treatment in written or electronic form. It is a critical aspect of nursing practice that involves documenting assessments, interventions, outcomes, and other relevant details about a patient's health status.
Documentation maps the patient's health journey by creating a comprehensive...
2.0K


