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AMERICAN UNIVERSITY OF BEIRUT INSTITUTIONAL REVIEW BOARD (IRB)Protocol Closure Report of Previously Approved Research Instructions: Complete this form when an approved human subject research project
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How to fill out protocol closure report of

01
Gather all necessary information and documentation related to the project.
02
Write a detailed summary of the project including its objectives, outcomes, and any issues encountered.
03
Include a section on lessons learned and recommendations for future projects.
04
Obtain approval from all relevant stakeholders before finalizing the report.
05
Check for any formatting or grammatical errors before submitting the report.

Who needs protocol closure report of?

01
Project managers
02
Stakeholders
03
Regulatory authorities

What is Protocol Closure Report of Previously Approved Research Form?

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The protocol closure report is a document that summarizes the completion and closure of a specific protocol, such as a clinical trial or research study, indicating that all activities and data collection associated with the protocol have been finalized.
Typically, the principal investigator or the sponsor of the study is required to file the protocol closure report, as they are responsible for ensuring compliance with regulatory and institutional requirements.
To fill out a protocol closure report, one must provide key details about the study, including the protocol title, study number, summary of the activities conducted, data analysis results, and confirmation that all monitoring and reporting obligations have been met.
The purpose of the protocol closure report is to formally document the end of a protocol, provide an account of the study's findings, ensure accountability, and fulfill regulatory compliance.
The report must include information such as study title, principal investigator's details, dates of the study, total participants enrolled, summary of results, compliance with regulatory requirements, and any adverse events encountered.
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