Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Knowledge and adoption of GCP ICH E6(R3) principles
研究概览
简要总结
This observational cross-sectional study aims to assess knowledge, beliefs, and perceived barriers related to the application of Good Clinical Practice according to ICH E6(R3) among professionals involved in clinical research in Italy.
The study is conducted through a national web-based survey addressing practical competencies, organizational barriers, and training needs across different clinical research roles. A nested sub-study evaluates self-efficacy among Study Coordinators in relation to regulatory compliance, operational coordination, and professional development.
详细描述
The revision of the ICH Good Clinical Practice guideline E6(R3) introduces a risk-based and Quality by Design approach with significant implications for the design and conduct of clinical research. Despite these regulatory advances, the implementation of GCP E6(R3) principles within Italian clinical research centers remains heterogeneous.
This study uses a cross-sectional, web-based survey to explore knowledge, beliefs, and perceived organizational barriers related to GCP R3 application among professionals involved in clinical research, including investigators, study coordinators, study nurses, data managers, and other research personnel.
The survey also investigates training priorities and organizational factors influencing compliance with GCP principles. A nested sub-study focuses on Study Coordinators, assessing perceived self-efficacy across key competency domains such as regulatory responsibilities, operational coordination, data governance, communication, and professional development.
Data are collected at a single time point through anonymous online questionnaires and analyzed using descriptive and exploratory statistical methods. The findings are intended to inform future training strategies and quality improvement initiatives in clinical research settings.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Health professionals or operators involved in clinical research activities in Italy
- •Provision of electronic informed consent
排除标准
- •Failure to provide informed consent
- •Incomplete or invalid survey submission
结局指标
主要结局
Knowledge and adoption of GCP ICH E6(R3) principles
时间窗: Day 1
Level of knowledge and application of Good Clinical Practice according to ICH E6(R3), assessed through a composite score derived from survey items evaluating practical competencies and adoption of GCP R3 principles among clinical research professionals.
次要结局
- Rerceived organizational and regulatory barriers to GCP R3 implementation(Day 1)
- Training needs related to GCP ICH E6(R3)(Day 1)
- Study Coordinator self-efficacy related to GCP R3 responsibilities(Day 1)