Clinical ResearchNCT07837895
GCP-R3 Clinical Practice Survey in Research Centers
An observational study of Clinical Research, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Clinical Research
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2026to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 years or older
- Health professionals or operators involved in clinical research activities in Italy
- Provision of electronic informed consent
Who cannot join
- Failure to provide informed consent
- Incomplete or invalid survey submission
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, Lazio, 00168
Daniele Napolitano, RN, +393382650440, daniele.napolitano@policlinicogemelli.it
About this study
Official title: Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers
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.
Read the detailed description
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.
This 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.
The 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.
Data 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.
- Conditions
- Clinical Research
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (3)
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.
Measured: Day 1
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.
Measured: Day 1
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start15 Jul 2026
- Primary completion15 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical ResearchStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniele Napolitano, RN, Principal investigator, Fondazione Policlinico A. Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837895
- Sponsor's protocol ID
- ID 27185 - GCP-R3 Survey
- Status last verified
- Apr 2026
- First submitted
- 29 Apr 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Beliefs, and Barriers in the Application of Good Clinical Practice ICH E6(R3) in Italian Clinical Research Centers
- ClinicalTrials.gov ID
- NCT07837895
- Acronym / sponsor ID
- ID 27185 - GCP-R3 Survey
- Conditions
- Clinical Research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 15 Jul 2026 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This 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.
The 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.
Data 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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 years or older
- Health professionals or operators involved in clinical research activities in Italy
- Provision of electronic informed consent
Key exclusion criteria (2 listed)
- Failure to provide informed consent
- Incomplete or invalid survey submission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Knowledge and adoption of GCP ICH E6(R3) principles
Time frame: Day 1
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.
3 secondary outcomes
Rerceived organizational and regulatory barriers to GCP R3 implementation
Time frame: Day 1
Training needs related to GCP ICH E6(R3)
Time frame: Day 1
Study Coordinator self-efficacy related to GCP R3 responsibilities
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
Related trials for Clinical Research
Not yet recruitingPhase 2
Extension Study of Safety and Tolerability of DDY391 in Participants With Moderate to Severe Psoriatic Arthritis (CDDY391A12201-extension)
Moderate to Severe Psoriatic Arthritis
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniele Napolitano, RN principal investigator
Fondazione Policlinico A. Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Clinical Research, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniele Napolitano, RN (+393382650440, daniele.napolitano@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge and adoption of GCP ICH E6(R3) principles (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.