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STUDY CLOSE OUT

STUDY CLOSE OUT. Definition. This relates to the closure of a study at a participating site once all subjects have completed the study and all data queries have been resolved. Note:. Close out is not a one-off visit but is a process that may take weeks to months to complete

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STUDY CLOSE OUT

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  1. STUDY CLOSE OUT KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  2. Definition • This relates to the closure of a study at a participating site once all subjects have completed the study and all data queries have been resolved. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  3. Note: • Close out is not a one-off visit but is a process that may take weeks to months to complete • Can have multiple close out visits • It is essential that data and information are retrievable and stored in a safe and logical manner. This process must be conducted in accordance with GCP and regulatory requirements. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  4. Key areas Use the study close out SOP to provide guidance but the key areas are as follows: • Study documentation • Data Management • IRB/RA • Drug Accountability • Sample storage KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  5. Study Documentation • Study filing: Ensure filing of documentation has been maintained throughout the study and provides a clear audit trail • Archiving: Meet archiving requirements and make corresponding arrangements KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  6. Data Management • Data Validation: Completed data entry and all queries are resolved. • Electronic Data: mainly sponsor responsibility • Serious Adverse Event (SAE) Reconciliation KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  7. IRB/RA • Inform IRB, RA (if applicable) and local institution. • The reason for premature termination of a site if study stopped early. • All relevant safety issues and safety updates at and after close-out • The date of site closure KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  8. Drug Accountability • Reconcile accountability, supply and inventory logs for the study product. • Ensure proper documentation for return of product or drug destruction. • Any deviations should be documented. KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  9. Sample storage • Ensure long-term storage of clinical samples meets the requirements and is documented e.g. storage of baseline(screening) malaria slides or exportation of pk samples KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

  10. Closing remarks • The study should be closed out such that its ready for an audit or inspection at a later date, as late as 10 years from now! KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

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