Get the free Study Close-Out Visit - Beaumont Health

Title:*Applicable to:Effective Date:Sponsor/Contract Research Organization (CRO) Monitoring Visits Beaumont Health01/11/2018Policy Owner:Document Type:Functional Area:Administrative DirectorPolicyClinical

How to fill out study close-out visit

How to fill out study close-out visit

1. Review the study protocol and any relevant study documents to ensure familiarity with the requirements for study close-out visit.
2. Prepare all necessary study close-out visit forms and documents.
3. Schedule a meeting with the study site staff to conduct the close-out visit.
4. During the visit, review study data and records to ensure completeness and accuracy.
5. Verify that all study equipment and supplies have been appropriately handled and accounted for.
6. Meet with the principal investigator and study team to discuss any outstanding issues or concerns.
7. Complete all required documentation and forms, including a study close-out report.
8. Ensure that all regulatory and ethical requirements have been met.
9. Conclude the visit by thanking the study site staff for their cooperation and support.
10. Follow up with any necessary actions or next steps identified during the close-out visit.

Who needs study close-out visit?

1. A study close-out visit is typically needed by researchers or study coordinators who are conducting clinical trials or other research studies.
2. It may also be required by regulatory bodies or sponsors to ensure that all study procedures and requirements have been properly completed.
3. The visit allows for a final review of study data and records, verification of compliance with ethical and regulatory guidelines, and closure of the study.

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What is study close-out visit?

A study close-out visit is the final visit conducted at the end of a research study to ensure all study procedures have been completed and the data is accurate.

Who is required to file study close-out visit?

The principal investigator or study coordinator is responsible for filing the study close-out visit.

How to fill out study close-out visit?

Study close-out visit report should be completed by documenting study procedures, data collection, and any outstanding issues or concerns.

What is the purpose of study close-out visit?

The purpose of study close-out visit is to ensure the research study has been conducted according to protocol, all data is accurate, and any issues are resolved.

What information must be reported on study close-out visit?

Information such as study procedures completed, data collected, any deviations from protocol, and resolution of any outstanding issues must be reported on study close-out visit.