GCP-R3 Clinical Practice Survey in Research Centers

NCT07837895 | Recruiting

• 1 other identifier: ID 27185 - GCP-R3 Survey
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Clinical Research

Outcome Measures

Primary Outcomes (1)

• Knowledge and adoption of GCP ICH E6(R3) principles

  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.

  Day 1

Secondary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of health professionals and research staff involved in clinical research activities in Italy, including investigators, study coordinators, study nurses, data managers, monitors, and other research-related personnel.

You may qualify if:

• Age 18 years or older
• Health professionals or operators involved in clinical research activities in Italy
• Provision of electronic informed consent

You may not qualify if:

• Failure to provide informed consent
• Incomplete or invalid survey submission

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Study Officials

• Daniele Napolitano, RN

  Fondazione Policlinico A. Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniele Napolitano, RN

CONTACT

+393382650440; daniele.napolitano@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2026
• First Posted: September 24, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 24, 2026

Record last verified: 2026-04

Locations

IT (1)