GCP-R3 Clinical Practice Survey in Research Centers
ConditionClinical Research
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age 18 years or older
Health professionals or operators involved in clinical research activities in Italy
Provision of electronic informed consent
Disqualifiers
Failure to provide informed consent
Incomplete or invalid survey submission
Trial 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.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
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.
Time frame
Day 1Secondary outcomes
1
Rerceived organizational and regulatory barriers to GCP R3 implementation
Identification of perceived organizational, cultural, and operational barriers related to the implementation of GCP ICH E6(R3) in clinical research settings, as reported through structured survey items.
Time frame
Day 12
Training needs related to GCP ICH E6(R3)
Assessment of priority training areas related to GCP ICH E6(R3), based on responses regarding perceived gaps in knowledge and competencies across different clinical research roles.
Time frame
Day 13
Study Coordinator self-efficacy related to GCP R3 responsibilities
Evaluation of perceived self-efficacy among Study Coordinators across key competency domains, including regulatory compliance, operational coordination, data management, communication, and professional development, measured using the Study Coordinator Self-Efficacy Scale (SC-SES).
Time frame
Day 1Sponsors and contacts
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Source ClinicalTrials.gov