Clinical Research Directory

GCP-R3 Clinical Practice Survey in Research Centers

Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Summary

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.

Official title: Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers

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