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Investigator Site Closeout Procedure POLICY DETAILSDocument TypeStandard Operating Procedure PHOTO/CT/SOP16.0Document nameInvestigator Site Closeout ProcedureVersionFinal Version 5.2 22/Sep/2022Effective

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How to fill out investigator site close-out procedure

01

Collect all necessary documents and records related to the study from the investigator site.

02

Ensure all data is properly reviewed and organized before closing out the site.

03

Notify relevant parties such as sponsors, IRBs, and regulatory authorities of the site closure.

04

Conduct a final review of all documents to ensure completeness and accuracy.

05

Complete any required forms or reports for the site close-out procedure.

06

Archive all study documents according to regulatory requirements.

07

Ensure all study-related equipment and supplies are properly handled or disposed of.

Who needs investigator site close-out procedure?

01

Any research organization or sponsor conducting a clinical trial that involves investigator sites.

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What is investigator site close-out procedure?

Investigator site close-out procedure is the process followed to formally close a clinical trial site after the study has been completed.

Who is required to file investigator site close-out procedure?

The principal investigator is typically responsible for filing the investigator site close-out procedure.

How to fill out investigator site close-out procedure?

The investigator site close-out procedure should be filled out according to the specific instructions provided by the sponsor or regulatory authorities.

What is the purpose of investigator site close-out procedure?

The purpose of investigator site close-out procedure is to ensure that all necessary steps are taken to properly close a clinical trial site and meet regulatory requirements.

What information must be reported on investigator site close-out procedure?

Information such as final patient visit dates, medication returns, study document storage location, and any outstanding issues must be reported on the investigator site close-out procedure.

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