GCP-R3 Practice Survey for Italian Clinical Researchers
Official title: Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers
Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT07837895 · Data updated 2026-11-12
Researchers in Italy are taking a web survey to see how well they understand and apply GCP E6(R3) and to identify barriers and training needs.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Rome, Lazio) |
| Status | Recruiting |
| Started | July 15, 2026 |
| Main results expected | June 15, 2027 |
| Study ends | June 30, 2027 |
| Registry record updated | September 24, 2026 |
| Trial ID | NCT07837895 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are Italian health professionals or operators involved in clinical research who can provide informed consent.
✕Probably not a fit
Participants not involved in practical GCP implementation or without influence on training decisions may see limited personal benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a cross-sectional, web-based survey of professionals involved in clinical research in Italy to measure knowledge, beliefs, and barriers related to applying GCP E6(R3). It includes a nested sub-study on Study Coordinators to gauge self-efficacy in regulatory tasks, coordination, data governance, and professional development. The study uses anonymous questionnaires collected at a single time point and analyzes results with descriptive and exploratory statistics. The goal is to inform future training and quality improvement efforts in clinical research centers. The reconstruction emphasizes risk-based and Quality by Design aspects of GCP E6(R3) and how these translate into practical practice in Italian sites.
Why it matters
Potential benefit: If successful, findings could guide targeted training and organizational changes to improve adherence to GCP E6(R3) and overall research quality.
How similar studies have gone: Prior studies show that similar surveys can identify gaps in knowledge and barriers to GCP implementation, supporting the value of this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 years or older * Health professionals or operators involved in clinical research activities in Italy * Provision of electronic informed consent Exclusion Criteria: * Failure to provide informed consent * Incomplete or invalid survey submission
Where it's running
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, Italy Recruiting
Study contacts
- Principal investigator: Daniele Napolitano, RN — Fondazione Policlinico A. Gemelli IRCCS
- Study coordinator: Daniele Napolitano, RN
- Email: daniele.napolitano@policlinicogemelli.it
- Phone: +393382650440
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.