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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

STUDY CLOSE OUT

KEMRI-Wellcome Trust Research Programme Version: 4-Nov-2008

definition
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

slide3
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

key areas
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

study documentation
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

data management
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

irb ra
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

drug accountability
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

sample storage
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

closing remarks
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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