[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657521":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":26,"studyPopulation":27,"armGroups":23,"interventions":23,"overallOfficials":28,"centralContacts":33,"locations":38,"responsibleParty":55,"collaborators":23,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":23,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":65,"minAge":66,"maxAge":23,"enrollmentInfo":67,"targetDuration":23,"studyType":70,"phases":23,"briefSummary":71,"conditions":72,"keywords":23,"overallStatus":41,"whyStopped":23,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"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",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"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.",{"measure":18,"description":19,"timeFrame":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.",{"measure":21,"description":22,"timeFrame":12},"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).",null,{"allocation":23,"interventionModel":23,"interventionModelDescription":23,"primaryPurpose":23,"observationalModel":6,"timePerspective":25,"maskingInfo":23},"CROSS_SECTIONAL","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.\n\nThis 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.\n\nThe 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.\n\nData 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.","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.",[29],{"name":30,"affiliation":31,"role":32},"Daniele Napolitano, RN","Fondazione Policlinico A. Gemelli IRCCS","PRINCIPAL_INVESTIGATOR",[34],{"name":30,"role":35,"phone":36,"phoneExt":23,"email":37},"CONTACT","+393382650440","daniele.napolitano@policlinicogemelli.it",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Fondazione Policlinico Universitario A. Gemelli IRCCS","RECRUITING","Rome","Lazio","00168","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],12.51133,41.89193,{"lat":51,"lon":50},[54],{"name":30,"role":35,"phone":36,"phoneExt":23,"email":37},{"type":56,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100657521","gcp-r3-clinical-practice-survey-in-research-centers-100657521",false,"NCT07837895","GCP-R3 Clinical Practice Survey in Research Centers","Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers","Inclusion Criteria:\n\n* Age 18 years or older\n* Health professionals or operators involved in clinical research activities in Italy\n* Provision of electronic informed consent\n\nExclusion Criteria:\n\n* Failure to provide informed consent\n* Incomplete or invalid survey submission",true,"ALL","18 Years",{"count":68,"type":69},150,"ESTIMATED","OBSERVATIONAL","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.\n\nThe 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.",[73],"Clinical Research","2026-09-18",{"date":76,"type":77},"2026-09-24","ACTUAL",{"date":79,"type":77},"2026-07-15",{"date":81,"type":69},"2027-06-30",{"name":5,"class":6},1]