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This standard operating procedure (SOP) describes the procedures followed by key research personnel engaged in clinical research at Beaumont Hospitals (BH) during a close-out visit with a sponsor
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How to fill out study close-out visit
How to fill out STUDY CLOSE-OUT VISIT
01
Review the study protocol and any amendments to ensure all study objectives are met.
02
Prepare a close-out visit agenda and share it with study staff in advance.
03
Conduct a final review of all study documents and data for completeness and accuracy.
04
Ensure that all trial supplies are accounted for and properly disposed of or returned to the sponsor.
05
Interview study staff to gather feedback about the study processes and any challenges faced.
06
Confirm that all subject data has been entered into the database and is locked for analysis.
07
Ensure necessary regulatory documents are finalized and filed appropriately.
08
Prepare and distribute a close-out visit report summarizing the findings.
Who needs STUDY CLOSE-OUT VISIT?
01
Investigators running clinical trials.
02
Study coordinators and research staff involved in the study.
03
Regulatory bodies ensuring compliance with clinical trial standards.
04
Sponsors or funding organizations monitoring study progress.
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People Also Ask about
How do I close-out a study?
Closing out a study means a study is completed and no further identifiable data analysis is required and there are no more interventions or interactions with subjects. Initially, it is vital to confirm that all required source documentation and case report forms are complete, whether paper-based or electronic.
How do I close out a research paper?
The conclusion of a research paper has several key elements you should make sure to include: A restatement of the research problem. A summary of your key arguments and/or findings. A short discussion of the implications of your research.
What is a closed study?
A study should be closed when: • All research participants have completed all study-related interventions and procedures, including any follow-up; AND. • The research team has obtained all private identifiable data and/or specimens from all.
What is a study close out?
Study or trial closeout is the process by which all activities related to the clinical trial are reconciled, recorded, reported, and stored at the end of the trial.
What is the study close-out phase?
Study or trial closeout is the process by which all activities related to the clinical trial are reconciled, recorded, reported, and stored at the end of the trial.
How do I close a research study?
Study close-out activities should be initiated once participant enrollment and research activities (including all follow-up visits) have been completed and can consist of activities including but not limited to: Updating regulatory and oversight bodies of study status. Data clean up and electronic database lock.
How do I withdraw from a study?
When withdrawing from a study, let the research team know that you want to withdraw. The research team may ask why you want to leave the study. It can be helpful to have this information but you do not have to provide a reason if it makes you uncomfortable.
What is a close-out visit?
The Close-Out Visit (COV) is the last monitoring visit and thus completes the monitoring of the study. The site is ready for closure once the following criteria are met: In clinical studies: the last study participant has completed his or her last study visit.
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What is STUDY CLOSE-OUT VISIT?
A Study Close-Out Visit is the final assessment and wrap-up phase of a research study, where the research team ensures that all data has been collected, participants have been debriefed, and any remaining regulatory or ethical obligations have been fulfilled.
Who is required to file STUDY CLOSE-OUT VISIT?
The principal investigator (PI) and study coordinators are typically required to file the Study Close-Out Visit, ensuring that all necessary documentation and reports are completed and submitted to the relevant regulatory bodies.
How to fill out STUDY CLOSE-OUT VISIT?
To fill out the Study Close-Out Visit documentation, ensure that you complete all required sections by providing accurate information regarding study completion, participant follow-up, data management, and any outstanding issues or notes about the study.
What is the purpose of STUDY CLOSE-OUT VISIT?
The purpose of the Study Close-Out Visit is to formally conclude the study, ensuring compliance with regulatory requirements, safeguarding participant welfare, and securing the integrity of the data collected.
What information must be reported on STUDY CLOSE-OUT VISIT?
Information that must be reported includes the status of all participants, completion of data collection, results of any follow-up procedures, unresolved issues, and confirmation that all study materials and records are organized and stored according to regulatory guidelines.
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