GCP-R3 Clinical Practice Survey in Research Centers

Overview

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.

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.

Conditions