:ICH E8

Madeleine Whitehead1, Melissa Suprin2, Tashan Mistree3

  • 1Roche, Hexagon Place, Shire Park, Falcon Way, Welwyn Garden City, AL7 1TW, UK. madeleine.whitehead@roche.com.

概括

国际协调理事会更新了良好的临床实践 (GCP) 指南,转向积极主动的,基于风险的方法. 本文阐明了关键的ICH E8主题,如设计质量 (QbD) 和质量关键 (CtQ),以改善临床开发.

相关概念视频

Healthcare Associated Infections II: Preventive Measures01:22

Healthcare Associated Infections II: Preventive Measures

Essential infection prevention measures are based on the knowledge of the infection chain, the modes of transmission in healthcare settings, and the use of the best practices in all healthcare settings. Compulsory public reporting of healthcare-associated infection rates is needed to allow individuals and the community to make informed choices regarding selecting a healthcare facility.
The best practices for preventing healthcare-associated infections include hand hygiene, patient risk...
2.6K
Standards of Care II01:19

Standards of Care II

Nurses bear specific legal responsibilities under several federal statutes, including:
656
Standards of Care I01:22

Standards of Care I

Federal statutes profoundly impact nursing practice, providing critical guidelines to ensure patient care is equitable, accessible, and of the highest quality. The following laws address distinct aspects of healthcare provision and patient rights:
697
Nursing Clinical Information System01:27

Nursing Clinical Information System

Nursing Clinical Information System (NCIS)
A Nursing Clinical Information System (NCIS) is a specialized type of healthcare information system tailored to meet the unique needs of nursing practice. It incorporates the principles of nursing informatics to streamline information management and improve the quality of care delivery.
Critical attributes of NCIS include:
780
Methods of Documentation V: CBE01:23

Methods of Documentation V: CBE

Charting by Exception, or CBE, is a method of documentation used in healthcare, particularly in nursing, that focuses on documenting only significant or abnormal findings rather than recording every detail. This approach aims to streamline the documentation process, improve efficiency, and ensure that healthcare providers can quickly identify deviations from normalcy in patient assessments.
In CBE, healthcare professionals establish predefined standards of practice that define what constitutes...
906
Methods of Documentation VII: EMR01:30

Methods of Documentation VII: EMR

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...
839