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This policy provides guidance in reporting study completion and closure to the Human Investigation Committee (HIC), including the submission of a Final Report / Closure Form, applicable to all investigators
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How to fill out study completion closure or
How to fill out STUDY COMPLETION, CLOSURE OR EXPIRATION
01
Begin by gathering all necessary study documentation and results.
02
Complete the STUDY COMPLETION form with accurate participant data.
03
Summarize key findings and conclusions derived from the study.
04
Outline any follow-up actions or recommendations based on the study results.
05
Review the documentation for accuracy and completeness.
06
Submit the completed form to the appropriate regulatory body or institution.
Who needs STUDY COMPLETION, CLOSURE OR EXPIRATION?
01
Researchers who have completed a clinical trial or study.
02
Institutional Review Boards (IRBs) for oversight and record-keeping.
03
Sponsors of the study for compliance and reporting purposes.
04
Regulatory agencies to ensure adherence to guidelines.
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People Also Ask about
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 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.
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.
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 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.
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 closeout?
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.
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What is STUDY COMPLETION, CLOSURE OR EXPIRATION?
STUDY COMPLETION, CLOSURE OR EXPIRATION refers to the formal process of concluding a research study, which may occur when the study has reached its planned endpoints, when it is prematurely stopped, or when the designated study period has elapsed.
Who is required to file STUDY COMPLETION, CLOSURE OR EXPIRATION?
The principal investigator or sponsor of the research study is typically required to file for STUDY COMPLETION, CLOSURE OR EXPIRATION to formally notify regulatory bodies or oversight committees.
How to fill out STUDY COMPLETION, CLOSURE OR EXPIRATION?
To fill out STUDY COMPLETION, CLOSURE OR EXPIRATION, one must complete the designated forms provided by the relevant regulatory agency, including detailed information about the study, its results, and the reasons for completion or closure.
What is the purpose of STUDY COMPLETION, CLOSURE OR EXPIRATION?
The purpose of STUDY COMPLETION, CLOSURE OR EXPIRATION is to formalize the end of a research study, ensure compliance with regulatory requirements, and provide an opportunity to report findings and outcomes.
What information must be reported on STUDY COMPLETION, CLOSURE OR EXPIRATION?
On STUDY COMPLETION, CLOSURE OR EXPIRATION, information that must be reported includes the study title, identification number, reasons for study closure or completion, summary of results, and any significant findings or outcome measures.
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